Medical devices for the identification and treatment of bodily passages

ABSTRACT

Medical devices are described. More particularly, medical devices and methods for the identification and treatment of bodily passages, such as sinus cavities, are described herein. An exemplary medical device comprises an elongate member, a handle, and a wire member. The elongate member is moveable between a first straight, or substantially straight, configuration to a second curved configuration.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/704,652, filed Sep. 24, 2012. The entire contents of this relatedapplication is hereby incorporated into this disclosure by reference.

FIELD

The disclosure relates generally to medical devices. More particularly,the disclosure relates to medical devices and methods for theidentification and treatment of bodily passages, such as sinus cavities.

BACKGROUND

It is sometimes necessary or otherwise desirable to identify and treat abodily passage, such as a sinus cavity. For example, when sinus cavitiesbecome blocked, balloon sinuplasty—the dilation of the sinus using aballoon catheter—provides an alternative to radical surgical approachesto unblocking the sinus cavity. Conventional procedures utilize twoseparate devices to accomplish balloon sinuplasty, a rigid scope and aguiding catheter. The scope is utilized to locate the point of treatmentand to provide visualization throughout the treatment process and theguiding catheter is used to guide a treatment device to the point oftreatment.

Advancing a scope and guiding catheter separately towards a point oftreatment has significant drawbacks because it increases the complexityof the procedure and the amount of time required to complete theprocedure. For example, the individual performing the procedure must useboth hands to manipulate the scope and guiding catheter. Doing so isawkward and, in some cases, requires an assistant to complete theprocedure. Furthermore, due to the tortuous anatomy of many bodilypassages, physicians generally must maintain a variety of scopes andguiding catheters that have many different angle configurations so thatparticular devices with appropriate configurations can be selected atthe time of treatment.

Scopes have been developed that include a deflectable tip, which allowsphysicians to view various portions of a bodily passage during theperformance of a procedure. However, these scopes still presentsignificant drawbacks. For example, scopes that include deflectable tipsare rigid in nature, which limits their ability to be navigated throughthe tortuous anatomy of a bodily passage. In addition, these scopes donot incorporate a flexible material or a mechanism for transitioningbetween a rigid configuration and a flexible configuration during theperformance of a procedure. This prevents adjustment of the scope duringthe procedure such that the scope can be adapted to the anatomy of abodily passage, for example, when it is desired to pass the scopethrough an opening defined by the bodily passage.

A need exists, therefore, for improved medical devices and methods foridentifying and treating a bodily passage, such as a sinus cavity.

SUMMARY

Various exemplary medical devices are described.

A first exemplary medical device comprises an elongate member, a handle,a wire member, and a cannula. The elongate member has an elongate memberproximal end, an elongate member distal end, and defines a first lumenand a second lumen. The handle is disposed on the elongate member andhas an actuator moveable between an actuator first position and anactuator second position. The actuator has a first portion and a secondportion. The wire member has a wire member first end attached to thefirst portion of the actuator and a wire member second end disposedwithin the first lumen and attached to the elongate member. The cannulahas a cannula proximal end attached to the second portion of theactuator and a cannula distal end disposed within the second lumen. Thecannula is moveable between a cannula first position when the actuatoris in the actuator first position and a cannula second position when theactuator is in the actuator second position. In the cannula firstposition the cannula distal end is disposed at a first location. In thecannula second position the cannula distal end is disposed at a secondlocation that is proximal to the first location. The elongate member ismoveable between a substantially straight configuration when theactuator is in the actuator first position and a curved configurationwhen the actuator is in the actuator second position.

A second exemplary medical device comprises an elongate member, ahandle, a wire member, and a cannula. The elongate member has anelongate member proximal end, an elongate member distal end, and definesa first lumen and a second lumen. The handle is disposed on the elongatemember and has an actuator moveable between an actuator first positionand an actuator second position. The actuator has a first portion and asecond portion. The wire member has a wire member first end attached tothe first portion of the actuator and a wire member second end disposedwithin the first lumen and attached to the elongate member. The cannulahas a cannula proximal end attached to the second portion of theactuator and a cannula distal end disposed within the second lumen. Thecannula is moveable between a cannula first position when the actuatoris in the actuator first position and a cannula second position when theactuator is in the actuator second position. In the cannula firstposition the cannula distal end is disposed at a first location. In thecannula second position the cannula distal end is disposed at a secondlocation that is proximal to the first location. The elongate member ismoveable between a substantially straight configuration when theactuator is in the actuator first position and a curved configurationwhen the actuator is in the actuator second position. The cannula isformed of a substantially rigid material.

A third exemplary medical device comprises an elongate member, a handle,a wire member, and a cannula. The elongate member has an elongate memberproximal end, an elongate member distal end, an elongate member firstportion, an elongate member second portion, and defines a first lumenand a second lumen. The elongate member first portion extends from theelongate member proximal end towards the elongate member distal end to alocation between the elongate member proximal end and the elongatemember distal end. The elongate member second portion extends from theelongate member distal end towards the elongate member proximal end to alocation between the elongate member proximal end and the elongatemember distal end. The handle is disposed on the elongate member and hasan actuator moveable between an actuator first position and an actuatorsecond position. The actuator has a first portion and a second portion.The wire member has a wire member first end attached to the firstportion of the actuator and a wire member second end disposed within thefirst lumen and attached to the elongate member. The cannula has acannula proximal end attached to the second portion of the actuator anda cannula distal end disposed within the second lumen. The cannula ismoveable between a cannula first position when the actuator is in theactuator first position and a cannula second position when the actuatoris in the actuator second position. In the cannula first position thecannula distal end is disposed at a first location. In the cannulasecond position the cannula distal end is disposed at a second locationthat is proximal to the first location. The elongate member is moveablebetween a substantially straight configuration when the actuator is inthe actuator first position and a curved configuration when the actuatoris in the actuator second position. The elongate member first portion isformed of a first material and the elongate member second portion isformed of a second material. The second material is flexible relative tothe first material. The cannula is formed of a substantially rigidmaterial.

Additional understanding of the exemplary medical devices can beobtained by review of the detailed description, below, and the appendeddrawings.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a side view of a first exemplary medical device in a firstconfiguration.

FIG. 1A is a sectional view of the medical device illustrated in FIG. 1,taken along line 1A-1A.

FIG. 2 is a sectional view of the medical device illustrated in FIG. 1,taken along line 2-2.

FIG. 3 is a side view of the medical device illustrated in FIG. 1 in asecond configuration.

FIG. 4 is a sectional view of the distal end of an alternative elongatemember of a medical device.

FIG. 5 is a sectional view of the distal end of a second alternativeelongate member of a medical device.

FIG. 5A is a sectional view of the alternative elongate memberillustrated in FIG. 5, taken along line 5A-5A.

FIG. 6 is a side view of a second exemplary medical device in a firstconfiguration.

FIG. 6A is a magnified view of area 6A indicated in FIG. 6.

FIG. 7 is a sectional view of the medical device illustrated in FIG. 6,taken along line 7-7.

FIG. 8 is a side view of the medical device illustrated in FIG. 6 in asecond configuration.

FIG. 9 is a side view of an alternative cannula of a medical device.

FIG. 10 is a side view of an exemplary catheter.

FIG. 11 is a side view of the catheter illustrated in FIG. 10 passedthrough a lumen of the second exemplary medical device illustrated inFIGS. 6, 6A, 7, and 8.

FIG. 12 is a side view of a third exemplary medical device.

FIG. 12A is a sectional view of the medical device illustrated in FIG.12, taken along line 12A-12A.

FIG. 13 is a perspective view of the proximal end of a fourth exemplarymedical device.

FIG. 14 is a side view of the proximal end of the medical deviceillustrated in FIG. 13.

FIG. 14A is a sectional view of the medical device illustrated in FIG.14, taken along line 14A-14A.

FIG. 15 is a side view of a first alternative method of connecting awire member to an actuator.

FIG. 16 is a side view of a second alternative method of connecting awire member to an actuator.

FIG. 17 is a side view of a third alternative method of connecting awire member to an actuator.

FIG. 18 is a flowchart representation of a method of treatment.

FIG. 19 is a flowchart representation of another method of treatment.

DETAILED DESCRIPTION

The following detailed description and the appended drawings describeand illustrate various exemplary medical devices and methods oftreatment. The description and drawings are exemplary in nature and areprovided to enable one skilled in the art to make and use one or moreexemplary medical devices and practice one or more of the methodsdescribed herein. They are not intended to limit the scope of the claimsin any manner.

The use of “e.g.,” “etc.,” “for instance,” “in example,” and “or” andgrammatically related terms indicates non-exclusive alternatives withoutlimitation, unless otherwise noted. The use of “exemplary” refers to “anexample of” and is not intended to convey a meaning of an ideal orpreferred embodiment. As used herein, the terms “proximal” and “distal”are used to describe opposing axial ends of the particular elements orfeatures being described. The use of “bodily passage” or “body passage”refers to any passage within the body of an animal, including, but notlimited to, humans, and includes elongate passages. The term “sinuspassage” refers to the nasal passages and includes, but is not limitedto, eustachian tube(s), primary ostium, accessory ostium, airways,and/or an opening defined by a ventilation tube. The term “sinus cavity”refers to the frontal, ethmoid, sphenoid, and/or maxillary sinus. Theuse of “attached” refers to the fixed, releasable, or integratedassociation of two or more elements and/or devices, unless otherwisenoted. Thus, the term “attached” includes releasably attaching orfixedly attaching, either permanently or temporarily, two or moreelements and/or devices, unless otherwise noted.

FIGS. 1, 1A, 2, and 3 illustrate an exemplary medical device 10comprising an elongate member 12, a handle 14, and a wire member 16.

Elongate member 12 can have any suitable outside diameter and anysuitable length, and skilled artisans will be able to select a suitableoutside diameter and length for an elongate member according to aparticular embodiment based on various considerations, including thedesired bodily passage within which a medical device is intended to beused. The inventors have determined that elongate members having anoutside diameter between about 1 mm to about 7 mm are suitable. Theinventors have also determined that elongate members having an outsidediameter between about 3 mm to about 5 mm are suitable. Moreover, theinventors have determined that an elongate member having an outsidediameter about 4 mm is suitable. The inventors have determined thatelongate members having a length between about 10 cm to about 30 cm aresuitable. The inventors have also determined that elongate membershaving a length between about 15 cm to about 28 cm are suitable.

In the illustrated embodiment, elongate member 12 comprises an elongatemember proximal end 18, an elongate member distal end 20, an elongatemember first portion 22, an elongate member second portion 24, anddefines a first lumen 26 and a second lumen 28. Elongate member firstportion 22 extends from elongate member proximal end 18 towards elongatemember distal end 20 to a location between elongate member proximal end18 and elongate member distal end 20. Elongate member second portion 24extends from elongate member distal end 20 towards elongate memberproximal end 18 to a location between elongate member proximal end 18and elongate member distal end 20. In the illustrated embodiment, thedistal end of elongate member first portion 22 abuts the proximal end ofelongate member second portion 24 at elongate member junction 25, whichis located between elongate member proximal end 18 and elongate memberdistal end 20. Elongate member first portion 22 is formed of a firstmaterial that is rigid, or substantially rigid, and elongate membersecond portion 24 is formed of a second material that is flexible, orsubstantially flexible, relative to the material forming elongate memberfirst portion 22. The second material that forms elongate member secondportion 24 is different from the first material that forms elongatemember first portion 22. Elongate member 12 is adapted to move between astraight, or substantially straight, configuration, as illustrated inFIG. 1, to a curved configuration, as illustrated in FIG. 3.

In the illustrated embodiment, elongate member junction 25 comprises abutt joint between elongate member first portion 22 and elongate membersecond portion 24. While a butt joint has been illustrated and describedas attaching elongate member first portion 22 and elongate member secondportion 24, any suitable method of attachment between an elongate memberfirst portion and an elongate member second portion can be used. Skilledartisans will be able to select a suitable method of attachment betweenan elongate member first portion and an elongate member second portionaccording to a particular embodiment based on various considerations,including the nature of the materials forming the elongate member firstportion and the elongate member second portion. Example methods ofattachment considered suitable between an elongate member first portionand an elongate member second portion include, but are not limited to, abutt joint (as illustrated in FIGS. 1 and 3), a threaded joint, anoverlapped joint, and any other method of attachment considered suitablefor a particular application. It is considered advantageous to use abutt joint at least because this allows elongate member first portionand elongate member second portion to be contiguous to one another.Alternatively, an elongate member can be a single component such that afirst portion and second portion are integral with one another.

Elongate member first portion 22 and elongate member second portion 24can be formed of any suitable material and can be fabricated using anysuitable method. Skilled artisans will be able to select suitablematerials and methods of forming an elongate member first portion and anelongate member second portion according to a particular embodimentbased on various considerations, including the desired flexibility ofthe elongate member. Example materials considered suitable for anelongate member first portion include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nickel-titanium alloy (e.g.,Nitinol), polymers, Pebax (Pebax is a registered trademark of Ato ChimieCorporation of Allee des Vosges, Courbevoie, France), nylon,polyethylene, polyurethane, silicone, coiled materials, and braidedmaterials. Example materials considered suitable for an elongate membersecond portion include, but are not limited to, biocompatible materials,materials that can be made biocompatible, metals such as stainlesssteel, titanium, nickel-titanium alloy (e.g., Nitinol), polymers, Pebax,nylon, polyethylene, polyurethane, silicone, coiled materials, andbraided materials. Example methods of manufacturing an elongate memberinclude, but are not limited to, extrusion and molding processes.

For example, it is considered advantageous to form elongate member firstportion 22 of a metal, such as stainless steel, and elongate membersecond portion 24 of a polymer at least because this provides rigidityto the elongate member 12 while also providing flexibility to elongatemember second portion 24 such that it can define curve 64 as shown inFIG. 3.

Alternatively, an elongate member first portion and/or an elongatemember second portion can be formed by layering material(s) along thelength, or a portion of the length, of the elongate member first portionand/or elongate member second portion. For example, an elongate memberfirst portion and/or an elongate member second portion can be formed ofmultiple layers of the same material or multiple layers of differentmaterials. In instances where an elongate member first portion and/or anelongate member second portion are formed of multiple layers ofdifferent materials, each layer can comprise a different material, or afirst layer can comprise a first material and a second layer cancomprises a second material that is different than the first material.Any suitable combination of materials and/or layers of materials can beused to form an elongate member, an elongate member first portion,and/or an elongate member second portion.

While elongate member first portion 22 has been illustrated as having alength that is greater than the length of elongate member second portion24, an elongate member first portion and/or an elongate member secondportion can have any suitable length, and skilled artisans will be ableto select a suitable length for an elongate member first portion and/oran elongate member second portion according to a particular embodimentbased on various considerations, including the bodily passage withinwhich a medical device is intended to be used. For example, when anelongate member includes an elongate member first portion and anelongate member second portion, the inventors have determined thatelongate members that include an elongate member first portion that hasa length between about 10 cm to about 30 cm are suitable. In addition,when an elongate member includes an elongate member first portion and anelongate member second portion, the inventors have determined thatelongate members that include an elongate member first portion that hasa length between about 15 cm to about 25 cm are also suitable. Moreover,when an elongate member includes an elongate member first portion and anelongate member second portion, the inventors have determined thatelongate members that include an elongate member second portion that hasa length between about 0.5 cm to about 3.5 cm are suitable. Furthermore,when an elongate member includes an elongate member first portion and anelongate member second portion, the inventors have determined thatelongate members that include an elongate member second portion that hasa length between about 1 cm to about 3 cm are also suitable.

While elongate member 12 has been described and illustrated as having anelongate member first portion 22 formed of a first material and anelongate member second portion 24 formed of a second, different,material, an elongate member can be formed of any suitable number ofportions formed of any suitable number of materials, and skilledartisans will be able to select a suitable number of portions andmaterials to form an elongate member according to a particularembodiment based on various considerations, including the desired bodilypassage within which a medical device is intended to be used. Forexample, alternative to a medical device including an elongate memberhaving an elongate member first portion formed of a first material andan elongate member second portion formed of a second, different,material, an elongate member can be formed of the same material alongits entire length, of different forms and/or compositions of the samematerial along its entire length, or a portion thereof, or formed of aplurality of different materials, each having a portion defined alongthe length of the elongate member. It is considered advantageous to forman elongate member, or portion thereof (e.g., elongate member firstportion, elongate member second portion), of a braided material to addtorsional strength to the elongate member and provide torquability ofthe elongate member during use. It is also considered advantageous toform an elongate member, or portion thereof (e.g., elongate member firstportion, elongate member second portion), of a coiled material toprovide kink-resistance. Optionally, an elongate member, or portionthereof (e.g., elongate member first portion, elongate member secondportion), can be formed of both of a braided material and coiledmaterial, to add torsional strength to the elongate member, providetorquability of the elongate member during use, and to providekink-resistance.

For example, an elongate member can be a single continuous componentsuch that an elongate member first portion and an elongate member secondportion are integral with one another (e.g., junction 25 is omitted) andelongate member is formed of a single continuous material along itslength. The material forming the elongate member can have a hardnessthat changes from the elongate member proximal end to the elongatemember distal end (e.g., durometer hardness). The hardness at theelongate member proximal end, or elongate member first portion, can havea first quantity and the hardness at the elongate member distal end, orelongate member second portion, can have a second quantity that isdifferent than the first quantity such that the elongate member distalend, or elongate member second portion, is more flexible than theelongate member proximal end, or elongate member first portion. Thus,the hardness at the elongate member proximal end, or elongate memberfirst portion, can be greater than the hardness at the elongate memberdistal end, or the second portion of the elongate member, to providerigidity along the elongate member proximal end, or elongate memberfirst portion, and flexibility along the elongate member distal end, orelongate member second portion.

First lumen 26 extends from a first lumen first opening 30 disposeddistal to elongate member proximal end 18 along the length of elongatemember 12 between elongate member proximal end 18 and elongate memberdistal end 20 and a first lumen second opening 32 disposed at elongatemember distal end 20. Second lumen 28 extends from a second lumen firstopening 34 disposed at elongate member proximal end 18 and a secondlumen second opening 36 disposed at elongate member distal end 20.

The inclusion of second lumen 28 is considered advantageous at leastbecause it allows for the introduction of one or more secondary devicesthrough elongate member 12. Any suitable secondary device can be passedthrough an elongate member, and skilled artisans will be able to selecta suitable secondary device according to a particular embodiment basedon various considerations, including the desired treatment intended tobe performed. Example devices considered suitable to pass through alumen defined by an elongate member include, but are not limited to,catheters, balloon catheters, suction devices, graspers, cutting tools,illuminating members, optical fibers, cameras, chip-in-tip fiber optics,imaging devices, imaging fibers, and any other device consideredsuitable for a particular application. For example, an illuminatingmember can be passed through the lumen of an elongate member thatcomprises a light-emitting distal end, as described in more detailbelow.

While elongate member 12 has been illustrated and described as defininga first lumen 26 and a second lumen 28, an elongate member can defineany suitable number of lumens having any suitable diameter, and skilledartisans will be able to select a suitable number of lumens and suitablediameters according to a particular embodiment based on variousconsiderations, including the bodily passage within which the medicaldevice is intended to be used and/or the devices being used incombination with the elongate member. Example number of lumensconsidered suitable include, but are not limited to, one, at least one,two, a plurality, three, four, and any other number considered suitablefor a particular application. For example, it is considered advantageousfor a lumen (e.g., second lumen 28) of an elongate member that isadapted to receive and allow one or more secondary devices to passthrough the elongate member to have the largest suitable diameter. Forexample, second lumen 28 can have a diameter that is larger than anyother lumen defined by elongate member (e.g., first lumen 26).

Any portion, or the entirety, of the elongate member 12, first lumen 26,second lumen 28, or any other lumen defined by an elongate member, canbe lined and/or coated with any suitable material to reduce thecoefficient of friction between the outer surface of the elongate memberand the surface in which the outer surface is intended to, or may,contact, or the surface defining the lumen and the surface of a devicebeing passed through the lumen. Any suitable lining and/or coatingcapable of reducing the coefficient of friction is considered suitable,and skilled artisans will be able to select a suitable lining and/orcoating according to a particular embodiment based on variousconsiderations, such as the bodily passage within which the medicaldevice is intended to be used. A lining and/or coating can be includedalong any suitable portion, or the entirety, of the elongate memberlength. Example lubricious coatings considered suitable to reduce thecoefficient of friction include, but are not limited to, polymers suchas polyethylene (PE), polytetrafluoroethylene (PTFE), and any otherpolymer or substance having properties that result in the lowering ofthe coefficient of friction between two surfaces.

While first lumen first opening 30, first lumen second opening 32,second lumen first opening 34, and second lumen second opening 36 havebeen described and illustrated as positioned at particular locations onelongate member 12, the opening of a lumen can be positioned at anysuitable location on, or along the length of, an elongate member.Skilled artisans will be able to select a suitable location to positiona lumen opening according to a particular embodiment based on variousconsiderations, including the desired bodily passage within which amedical device is intended to be used. Example positions consideredsuitable to locate an opening of a lumen on an elongate member include,but are not limited to, on the elongate member proximal end, along thelength of an elongate member between the elongate member proximal endand the elongate member distal end, and on the elongate member distalend. For example, alternative to positioning a first lumen first openingalong the length of an elongate member between the elongate memberproximal end and the elongate member distal end, the first lumen firstopening can be positioned on the elongate member proximal end.Alternative to positioning a first lumen second opening on the elongatemember distal end, the first lumen second opening can be omitted and thefirst lumen can terminate proximal to the elongate member distal end andonly comprise a first opening.

Handle 14 can be formed of any suitable material, and skilled artisanswill be able to select a suitable material to form a handle according toa particular embodiment based on various considerations, including thedesired bodily passage within which a medical device is intended to beused. Example materials considered suitable to form a handle include,but are not limited to, biocompatible materials, materials that can bemade biocompatible, metals such as stainless steel, titanium,nickel-titanium alloy (e.g., Nitinol), polymers, Pebax, nylon,polyethylene, polyurethane, silicone, and braided materials.

In the illustrated embodiment, handle 14 is disposed along the length ofelongate member 12 between elongate member proximal end 18 and elongatemember distal end 20 and comprises a handle proximal end 35, a handledistal end 37, a housing 38, and an actuator 40. Housing 38 has ahousing wall 42 that defines a housing cavity 44, a first housingopening 46, a second housing opening 48, and a third housing opening 50.Each of the first housing opening 46, second housing opening 48, andthird housing opening 50 extends through the housing wall 42 andprovides access to housing cavity 44.

While handle 14 has been described and illustrated as disposed along thelength of elongate member 12 between elongate member proximal end 18 andelongate member distal end 20, the handle of a medical device can bepositioned at any suitable location on an elongate member. Skilledartisans will be able to select a suitable position for a handle on anelongate member according to a particular embodiment based on variousconsiderations, including the structural arrangement of the handle andmaterials forming the elongate member. Example locations consideredsuitable to position a handle on an elongate member include, but are notlimited to, positioning the handle on the elongate member proximal end,positioning the handle on an elongate member such that the elongatemember proximal end is disposed within a cavity defined by the handle,and positioning the handle on an elongate member such that the elongatemember proximal end is disposed on the handle distal end.

Positioning handle 14 along the length of elongate member 12 betweenelongate member proximal end 18 and elongate member distal end 20 isconsidered advantageous at least because it provides stability ofmedical device 10 during use and positions a portion of elongate member12 proximal to handle 14 such that the introduction of one or moresecondary medical devices can be accomplished.

In the illustrated embodiment, the handle proximal end 35 comprises ahandle first side 39, an opposably positioned handle second side 41, anda handle thickness 43. Each of the handle first side 39 and handlesecond side 41 has a round, or substantially round, perimeter thattapers to handle distal end 37, which has a tubular configuration. Thisstructural arrangement is considered advantageous at least because itallows one-handed operation of medical device 10 such that a user canboth maintain control of the medical device during use and activateactuator 40 to move elongate member 12 between a straight, orsubstantially straight, configuration, to a curved configuration, asdescribed herein. While handle 14 has been described and illustrated ashaving a particular structural arrangement, any suitable structuralarrangement of a handle is considered suitable for a medical device.Skilled artisans will be able to select a suitable structuralarrangement for a handle of a medical device according to a particularembodiment based on various considerations, including the structuralarrangement of the actuator being used. Example alternative structuralarrangements considered suitable for a handle include, but are notlimited to, linear, round, elliptical, oblong, and any other structuralarrangement considered suitable for a particular application.

Actuator 40 is moveable between an actuator first position, as shown inFIG. 1, and an actuator second position, as shown in FIG. 3. Movement ofactuator 40 between the actuator first position and the actuator secondposition results in movement of elongate member 12 between a firststraight, or substantially straight, configuration, as shown in FIG. 1,and a curved configuration, as shown in FIG. 3 and as described in moredetail below. Any suitable actuator can be used in a medical device, andskilled artisans will be able to select a suitable actuator to includein a medical device according to a particular embodiment based onvarious considerations, including the desired radius of curvaturedefined by an elongate member when the actuator is moved between anactuator first position and an actuator second position. Exampleactuators considered suitable for a medical device include, but are notlimited to, linear actuators, rotatable actuators, pivotable actuators,and electro-mechanical actuators.

As shown in the illustrated embodiment, an example of a suitableactuator 40 is lever 51 that comprises a lever first end 52 disposedwithin the housing cavity 44 and a lever second end 54 disposed outsideof housing cavity 44. Lever 51 extends through second housing opening48. Lever first end 52 is pivotably attached to housing wall 42 by pin56 that extends through an aperture defined by the wall of lever 51 suchthat lever 51 can move within second housing opening 48 between a leverfirst position and a lever second position. FIG. 1 illustrates lever 51in the lever first position and FIG. 3 illustrates lever 51 in the leversecond position.

While pin 56 has been illustrated and described as providing pivotableattachment between lever 51 and housing 38, any suitable method ofattachment between an actuator (e.g., lever) and a housing can be used.Skilled artisans will be able to select a suitable method of attachmentbetween an actuator and a housing according to a particular embodimentbased on various considerations, including the materials forming theactuator and the housing. An example method of attachment consideredsuitable between an actuator and a housing includes, but is not limitedto, using a threaded attachment device (e.g., screw), a shaft, and anyother method of attachment considered suitable for a particularapplication.

Wire member 16 can be formed of any suitable material, and skilledartisans will be able to select a suitable material for a wire member ofa medical device according to a particular embodiment based on variousconsiderations, including the material that forms an elongate member ofthe medical device. Example materials considered suitable to form a wiremember include, but are not limited to, biocompatible materials,materials that can be made biocompatible, braided materials, polymers,nylon, and metals such as stainless steel, titanium, and nickel-titaniumalloy (e.g., Nitinol).

In the illustrated embodiment, wire member 16 comprises a wire memberfirst end 58 and a wire member second end 60. Wire member first end 58is attached to a portion of actuator 40. In the illustrated embodiment,wire member first end 58 is attached to lever 51 between lever first end52 and lever second end 54. Wire member second end 60 is attached withinfirst lumen 26 proximal to elongate member distal end 20. In theillustrated embodiment, wire member first end 58 is bonded (e.g., usingan adhesive, welding, fusing) to lever 51.

While wire member first end 58 has been described and illustrated asbonded to lever 51, a wire member can be connected to an actuator (e.g.,lever 51) using any suitable method of attachment, and skilled artisanswill be able to select a suitable method of attachment between a wiremember and an actuator according to a particular embodiment based onvarious considerations, including the materials forming the wire memberand the actuator. Example methods of attachment are described herein andbelow with respect to FIGS. 15, 16, and 17. These examples, however, arenot limiting in nature and any suitable method of attachment between awire member and an actuator can be used.

FIG. 15 illustrates a first alternative method for attaching a wiremember to an actuator. In the illustrated embodiment, the wall of lever51′ defines an aperture 53′ that extends through lever 51′ between thelever first end 52′ and lever second end 54′ and from a first opening ona lever first side 55′ to a second opening on a lever second side 57′.Wire member first end 58′ comprises a stopper 59′ that has an outsidediameter that is greater than the diameter of aperture 53′. Wire member16′ is disposed through aperture 53′ until stopper 59′ contacts lever51′ preventing, or eliminating, further movement of wire member 16′through lever 51′.

Stopper 59′ can comprise any suitable structure and/or material and beattached to wire member 16′ using any suitable method, and skilledartisans will be able to select a suitable structure and/or material anda suitable method of attachment between a stopper and a wire memberaccording to a particular embodiment based on various considerations,including the materials forming the wire member. For example, a stoppercan comprise a separate element attached to a wire member (e.g., aseparate element crimped onto wire member). Alternatively, a stopper canbe integral with a wire member.

FIG. 16 illustrates a second alternative method for attaching a wiremember to an actuator. In the illustrated embodiment, wire member firstend 58″ is wrapped around lever 51″ between lever first end 52″ andlever second end 54″. At 59″ wire member 16″ is attached to lever 51″and/or to a portion of the wire member 16″ that is wrapped around lever51″. A wire member can be wrapped around an actuator (e.g., lever 51″)any suitable number of times and any suitable method of attachmentbetween a wire member and an actuator and/or a portion of the wiremember wrapped around the actuator can be used. Skilled artisans will beable to select a suitable number of times to wrap a wire member aroundan actuator and a suitable method of attachment between a wire memberand an actuator and/or a portion of the wire member that is wrappedaround the actuator according to a particular embodiment based onvarious considerations, including the material(s) forming the wiremember. For example, a wire member can be wrapped around an actuatorone, at least one, two, a plurality, three, four, five, six, seven, andany other number of times considered suitable for a particularapplication. Example methods of attachment considered suitable between awire member and an actuator and/or a portion of the wire member that iswrapped around an actuator include, but are not limited to, using anadhesive, welding, fusing, knotting the wire member, and any othermethod of attachment considered suitable for a particular application.

FIG. 17 illustrates a third alternative method for attaching a wiremember to an actuator. In the illustrated embodiment, the wall of lever51″′ defines an aperture 53″′ that extends through lever 51″′ betweenthe lever first end 52″′ and lever second end 54″′ and from a firstopening on a lever first side 55″′ to a second opening on a lever secondside 57″′. Wire member 16″′ is passed through aperture 53″′ and iswrapped around lever 51″′. At 59″′ wire member 16″′ is attached to lever51″′ or to a portion of the wire member 16″′ that is wrapped aroundlever 51″′. A wire member can be wrapped around an actuator (e.g. lever51″′) any suitable number of times and any suitable method of attachmentbetween a wire member and an actuator and/or a portion of the wiremember wrapped around the actuator can be used, as described herein.

While wire member second end 60 has been illustrated and described asattached within first lumen 26 proximal to elongate member distal end20, a wire member second end can be attached at any suitable point alongthe length of a lumen defined by an elongate member using any suitablemethod of attachment. Skilled artisans will be able to select a suitablepoint to attach a wire member second end within a lumen defined by anelongate member and a suitable method of attachment according to aparticular embodiment based on various considerations, including theaxial length of the elongate member and/or the radius of curvaturedesired to be achieved by the elongate member. For example, alternativeto wire member second end 60 being attached within first lumen 26proximal to elongate member distal end 20, a wire member second end canbe attached within a first lumen at the elongate member distal end, atthe distal end, outside of a lumen defined by the elongate member distalend, or proximal to the elongate member distal end between the elongatemember proximal end and the elongate member distal end. Example methodsof attachment between a wire member and an elongate member consideredsuitable including, but are not limited to, using an adhesive, welding,fusing (e.g., heat fusing), crimping a stopper on the wire member secondend, and any other method of attachment considered suitable for aparticular application. For example, a wire member second end cancomprise a stopper that has an outside diameter that is greater than theinside diameter of a portion of the lumen in which the wire member isdisposed (e.g., lumen can taper along its length, lumen can define ashoulder along its length, lumen can define a protuberance along itslength). Wire member second end can be disposed through the lumen in amanner that prevents proximal movement of the wire member second endwhen the stopper contacts the portion of the lumen that has a diameterthat is less than that of the stopper. Thus, preventing, or eliminating,further movement of wire member second end through the lumen.

Any suitable structure and/or material can be attached to wire member(e.g., wire member second end) using any suitable method, and skilledartisans will be able to select a suitable structure and/or material anda suitable method of attachment between a stopper and a wire memberaccording to a particular embodiment based on various considerations,including the materials forming the wire member. For example, a stoppercan comprise a separate element attached to a wire member (e.g., aseparate element crimped onto wire member). Alternatively, a stopper canbe integral with a wire member.

In use, movement of lever 51 away from elongate member distal end 20, asshown by arrow 62, from the lever first position, as shown in FIG. 1, tothe lever second position, as shown in FIG. 3, causes wire member 16 tomove in a proximal, or substantially proximal, direction such that wiremember first end 58 advances towards elongate member proximal end 18.This creates tension in wire member 16 that results in movement of wiremember second end 60 and elongate member second portion 24 such thatelongate member 12 moves from a straight, or substantially straight,configuration, as shown in FIG. 1, to a curved configuration, as shownin FIG. 3, in which elongate member 12 defines curve 64 at a radius ofcurvature 65. Movement of lever 51 towards elongate member distal end20, in a direction opposite that of arrow 62, reduces, or eliminates,tension in wire member 16 and results in elongate member 12 returning toits straight, or substantially straight, configuration.

The radius of curvature 65 defined by elongate member 12 can bedetermined based upon at least the material(s) forming elongate member12, the location of the lever second position, the length of elongatemember 12, the length of wire member 16, and/or the axial length ofsecond housing opening 48 as it relates to the length of handle 14. Forexample, if a smaller radius of curvature 65 is desired, the length ofwire member 16 can be reduced as it relates to elongate member 12 and/orthe axial length of second housing opening 48 can be increased as itrelates to the length of handle 14. Alternatively, if a greater radiusof curvature 65 is desired, the length of wire member 16 can beincreased as it relates to elongate member 12 and/or the axial length ofsecond housing opening 48 can be decreased as it relates to the lengthof handle 14. Alternatively, adjustment of lever 51 provides a mechanismfor manipulating the radius of curvature 65 defined by elongate member12. For example, advancing lever 51 from the lever first position in theproximal direction until the desired radius of curvature 65 is obtainedand stopping proximal advancement of lever 51 can achieve a desiredcurve 64. It is considered advantageous to eliminate, or substantiallyeliminate, residual tension in wire member 16 when lever 51 is in thelever first position (e.g., lever 51 is near, or at, the distal end ofsecond housing opening 48) at least because this configures elongatemember 12 such that it is straight, or substantially straight, along itslength.

Elongate member 12 can define curve 64 at any suitable radius ofcurvature 65, and skilled artisans will be able to select a suitableradius of curvature to define a curve according to a particularembodiment based on various considerations, including the desired bodilypassage within which a medical device is intended to be used. Exampleradii considered suitable to define a curve include, but are not limitedto, radii between about 1 mm to about 15 mm, and any other radius ofcurvature considered suitable for a particular application. Theinventors have determined that elongate members that are capabledefining a radius of curvature between about 3 mm to about 10 mm aresuitable.

It is considered advantageous to provide an elongate member 12 that isadapted to move between a straight, or substantially straight,configuration and a curved configuration at least because this allowsthe medical device 10 to be advanced through tortuous bodily passages,such as sinus passages, and provides a mechanism for transitioningbetween a rigid, or substantially rigid, configuration and a curvedconfiguration during the performance of a procedure. It is alsoconsidered advantageous to provide an elongate member 12 that is adaptedto move between a straight, or substantially straight, configuration anda curved configuration at least because it provides a mechanism forusing a single device to perform a procedure rather than conventionalmethods which require multiple devices (e.g., sheaths) to perform aprocedure. For example, advancement of medical device 10 into a sinuscavity can be accomplished by advancing the elongate member distal end20 in the straight, or substantially straight, configuration through anasal passage (e.g., nostril). Once a sinus passage is located, elongatemember 12 can be moved to the curved configuration by moving lever 51 toits second position such that elongate member distal end 20 can bepositioned and advanced through the sinus passage and into the sinuscavity.

FIG. 4 illustrates a sectional view of the distal end of an alternativeelongate member 112 of a medical device. Elongate member 112 is similarto elongate member 12 illustrated in FIGS. 1, 1A, 2, and 3, anddescribed above, except as detailed below. Reference numbers in FIG. 4refer to the same structural element or feature referenced by the samenumber in FIGS. 1, 1A, 2, and 3, offset by 100. Thus, elongate member112 defines a first lumen 126 and a second lumen 128.

In the illustrated embodiment, a portion of wire member 116 is disposedwithin first lumen 126 and elongate member 112 defines a third lumen 166that extends along the length of elongate member from a first opening onelongate member proximal end to a second opening on elongate memberdistal end. Inclusion of third lumen 166 is considered advantageous atleast because it allows for one or more devices, such as secondarydevices, to be passed through elongate member 112 (e.g., through secondlumen 128 and/or third lumen 166). For example, a balloon catheter canbe passed through second lumen 128 and an optical fiber can be passedthrough third lumen 166, as described below.

Any suitable secondary device can be passed through an elongate member,and skilled artisans will be able to select a suitable secondary deviceaccording to a particular embodiment based on various considerations,including the desired treatment intended to be performed. Exampledevices considered suitable to pass through a lumen defined by anelongate member include, but are not limited to, catheters, ballooncatheters, suction devices, graspers, cutting tools, illuminatingmembers, optical fibers, cameras, chip-in-tip fiber optics, imagingdevices, imaging fibers, and any other medical device consideredsuitable for a particular application. Alternative to passing asecondary device through an elongate member, a secondary device can bepreloaded within a lumen defined by an elongate member. For example,chip-in-tip fiber optics can be preloaded within a lumen defined by anelongate member.

FIGS. 5 and 5A illustrate sectional views of the distal end of a secondalternative elongate member 212 of a medical device. Elongate member 212is similar to elongate member 112 illustrated in FIG. 4, and describedabove, except as detailed below. Reference numbers in FIGS. 5 and 5Arefer to the same structural element or feature referenced by the samenumber in FIG. 4, offset by 100. Thus, elongate member 212 defines afirst lumen 226, a second lumen 228, and a third lumen 266 and a portionof wire member 216 is disposed within first lumen 226.

In the illustrated embodiment, alternative to forming elongate membersecond portion of a continuous material, elongate member second portion224 comprises an embedded coil member 268. Inclusion of coil member 268in an elongate member second portion 224 is considered advantageous atleast because it reduces the likelihood of elongate member 212 kinkingand/or buckling during use, for example, when elongate member 212 ismoved between the first straight, or substantially straight,configuration and the second curved configuration.

Coil member 268 can extend along a portion or the entirety of the lengthof elongate member second portion 224 and/or elongate member 212.Example arrangements considered suitable for a coil member 268 include,but are not limited to, a coil member that extends from the elongatemember proximal end to the elongate member distal end, a coil memberthat extends from the elongate member proximal end to the elongatemember second portion, a coil member that extends from the elongatemember proximal end to a point proximal to the elongate member secondportion, a coil member that extends from a point distal to the elongatemember proximal end to the elongate member distal end, a coil memberthat extends from a point distal to the elongate member proximal end tothe elongate member second portion, a coil member that extends from apoint distal to the elongate member proximal end to a point proximal tothe elongate member second portion, a coil member that extends from theproximal end of the elongate member second portion to the elongatemember distal end, a coil member that extends from a point distal to theproximal end of the elongate member second portion to the elongatemember distal end, and a coil member that extends from a point distal tothe proximal end of the elongate member second portion to a pointproximal to the elongate member distal end. Alternatively, a coil membercan be embedded within an elongate member, a first portion, and/or asecond portion and disposed radially outward of, or about, one or morelumens defined by the elongate member. For example, a coil member can beembedded within an elongate member such that it is disposed radiallyoutward of, or about, a first lumen, second lumen, and/or third lumendefined by the elongate member (e.g., first lumen 226, second lumen 228,third lumen 266).

Coil member 268 can be formed of any suitable material and have anysuitable number of turns, and skilled artisans will be able to select asuitable material and number of turns for a coil member according to aparticular embodiment based on various considerations, including thedesired flexibility of the medical device. Example materials consideredsuitable for a coil member include but are not limited to, biocompatiblematerials, materials that can be made biocompatible, metals such asstainless steel, titanium, nickel-titanium alloy (e.g., Nitinol), andany other material considered suitable for a particular application.Example number of turns considered suitable for a coil member include,but are not limited to, one, at least one, two, a plurality, three,four, five, six, seven, eight, nine, ten, and any other numberconsidered suitable for a particular application. In addition, each turnof a coil member can be positioned at any suitable length from anadjacent turn of the coil member. For example, a coil member cancomprise equally width spaces between each turn of the coil member, or acoil member can comprise varying width spaces between each turn of thecoil member.

In addition, while a single coil member has been described andillustrated herein, any suitable number of coil members can be usedalong any length of an elongate member, and skilled artisans will beable to select a suitable number of coil members according to aparticular embodiment based on various considerations, including thedesired bodily passage within which a medical device is intended to bedisposed. Example number of coil members considered suitable include,but are not limited to, one, at least one, two, a plurality, three,four, and any other number considered suitable for a particularapplication.

Alternative to, or in combination with, including a coil member 268, anelongate member can comprise a braided material embedded within theelongate member, an elongate member first portion, and/or an elongatemember second portion and disposed radially outward, or about, one ormore lumens defined by the elongate member. For example, a coil membercan be embedded within an elongate member such that it is disposedradially outward, or about, a second lumen defined by the elongatemember (e.g., second lumen 228) and a braided material can be embeddedwithin the elongate member such that it is disposed radially outward, orabout, all of the lumens defined by the elongate member.

FIGS. 6, 6A, 7, and 8 illustrate another exemplary medical device 310.Medical device 310 is similar to medical device 10 illustrated in FIGS.1, 1A, 2, and 3, and described above, except as detailed below.Reference numbers in FIGS. 6, 6A, 7, and 8 refer to the same structuralelement or feature referenced by the same number in FIGS. 1, 1A, 2, and3, offset by 300. Thus, medical device 310 comprises an elongate member312, a handle 314, and a wire member 316.

In the illustrated embodiment, medical device 310 comprises a cannula370 that is partially disposed through elongate member 312 and handle314. Handle 314 comprises an actuator 340, a locking mechanism 376, anddefines a housing passageway 378 that extends from the exterior ofhousing 338 to the elongate member proximal end 318. Actuator 340comprises a lever 351, a support arm 372, and a connecting member 374.

In the illustrated embodiment, elongate member 312 defines a third lumen366 and does not include an elongate member first portion and anelongate member second portion formed of different materials. Rather,elongate member 312 is formed of the same material along its length. Itis to be understood, however, that any suitable elongate memberconfiguration, such as those described herein, can be used incombination with medical device 310. For example, alternative toelongate member 312 being formed of the same material along its length,an elongate material can comprise an elongate member first portion andan elongate member second portion, as described herein. Elongate member312 has an elongate member proximal end 318, an elongate member distalend 320, and defines a first lumen 326, a second lumen 328, and a thirdlumen 366. The first lumen 326 extends from a first lumen first opening330 positioned between elongate member proximal end 318 and elongatemember distal end 320 to a first lumen second opening 332 on theelongate member distal end 320. The second lumen 328 extends from asecond lumen first opening 334 on elongate member proximal end 318 to asecond lumen second opening 336 on elongate member distal end 320. Thethird lumen 366 extends from a third lumen first opening 380 on elongatemember proximal end 318 to a third lumen second opening 382 on elongatemember distal end 320.

While first lumen first opening 330, first lumen second opening 332,second lumen first opening 334, second lumen second opening 336, thirdlumen first opening 380, and third lumen second opening 382 have beendescribed and illustrated as positioned at particular locations onelongate member 312, the opening of a lumen can be positioned at anysuitable location on, or along the length of, an elongate member.Skilled artisans will be able to select a suitable location to positionan opening of a lumen according to a particular embodiment based onvarious considerations, including the structural arrangement of thehandle of a medical device. Example positions considered suitable tolocate a lumen opening on an elongate member include, but are notlimited to, on the elongate member proximal end, along the length of theelongate member, on the elongate member distal end, and any otherposition considered suitable for a particular application, such as thosedescribed herein. For example, alternative to positioning a third lumenfirst opening on the elongate member proximal end, the third lumen firstopening can be positioned along the length of the elongate memberbetween elongate member proximal end and elongate member distal end.

While elongate member 312 has been described as formed of a singlematerial along its length, an elongate member can be formed of one ormore portions each formed of different materials, as described above.For example, alternative to elongate member 312 being formed of a singlematerial along its length, the elongate member can comprise an elongatemember first portion formed of a first material that is rigid, orsubstantially rigid, and an elongate member second portion formed of asecond material, different from the first material, that is flexible, orsubstantially flexible, relative to the first material, as describedherein.

In the illustrated embodiment, handle 314 is disposed on elongate memberproximal end 318 such that elongate member proximal end 318 ispositioned within housing cavity 344. This is considered advantageous atleast because it provides stability of medical device 310 during use andlimits the devices and/or structures positioned proximal to handle 314.

Cannula 370 can be formed of any suitable material and have any suitablelength and outside diameter, and skilled artisans will be able to selecta suitable material, length, and diameter for a cannula according to aparticular embodiment based on various considerations, including thematerial(s) forming the elongate member and/or the structuralarrangement of the elongate member. Example materials consideredsuitable to form a cannula include, but are not limited to,biocompatible materials, materials that can be made biocompatible,metals such as stainless steel, titanium, nickel-titanium alloy (e.g.,Nitinol), polymers, rigid polymers, and any other material consideredsuitable for a particular application. It is considered advantageous toform cannula 370 of a rigid, or substantially rigid, material (e.g.,metal, rigid polymer) at least because this provides rigidity toelongate member 312 during use. For example, a cannula can be formed ofa material that is rigid relative to the material(s) that form theelongate member of a medical device (e.g., elongate member firstportion, elongate member second portion). Example lengths consideredsuitable for a cannula include, but are not limited to, a length that isgreater than the length of the elongate member, and a length that isgreater than the distance between the first opening of the housing andthe distal end of the elongate member.

Cannula 370 comprises a cannula proximal end 384, a cannula distal end386, and defines a cannula lumen 388 that extends from a cannula firstopening 390 on the cannula proximal end 384 to a cannula second opening392 on the cannula distal end 386. Cannula 370 is slidingly disposedthrough a portion of housing 338 and a portion of elongate member 312.Cannula 370 is slidingly disposed through first housing opening 346 suchthat the cannula proximal end 384 is disposed proximal to housing 338and outside of housing cavity 344 and cannula distal end 386 isslidingly disposed within second lumen 328 of elongate member 312. Thus,a portion of the length of cannula 370 is slidingly disposed withinsecond lumen 328 of elongate member 312.

In the illustrated embodiment, lever 351 has a lever first end 352disposed within the housing cavity 344, a lever second end 354 disposedoutside of housing cavity 344, and defines a plurality of leverprotuberances 394. Lever 351 is pivotably attached to housing wall 342by pin 356, which is disposed between the lever first end 352 and thelever second end 354, and extends through an aperture defined by thewall of lever 351. The plurality of lever protuberances 394 is definedon a portion of lever second end 354 and each protuberance of theplurality of protuberances extends outwardly and away from lever 351.Lever 351 is adapted to move within housing second opening 348 between alever first position and a lever second position. FIG. 6 illustrateslever 351 in the lever first position and FIG. 8 illustrates lever 351in the lever second position.

Support arm 372 and connecting member 374 can be formed of any suitablematerial, and skilled artisans will be able to select a suitablematerial to form a support arm and/or connecting member according to aparticular embodiment based on various considerations, including thematerials that form cannula and/or lever. Example materials consideredsuitable for a support arm and/or connecting member include, but are notlimited to, biocompatible materials, materials that can be madebiocompatible, metals such as stainless steel, titanium, nickel-titaniumalloy (e.g., Nitinol), polymers, Pebax, nylon, polyethylene,polyurethane, and silicone.

Support arm 372 has a support arm first end 396 and a support arm secondend 398. Support arm first end 396 is pivotably attached to lever firstend 352 by pin 397 that extends through a first aperture defined by thewall of support arm 372 and an aperture defined by the wall of lever351. Support arm second end 398 is pivotably attached to connectingmember 374 by pin 399 that extends through a second aperture defined bythe wall of support arm 372.

Connecting member 374 has a connecting member proximal end 400, aconnecting member distal end 402, and defines a connecting member lumen404 that extends from a first opening on connecting member proximal end400 to a second opening on connecting member distal end 402. Connectingmember 374 is attached to cannula 370 between the cannula proximal end384 and cannula distal end 386. Thus, connecting member 374 is slidinglydisposed through first housing opening 346 and cannula 370 is attachedto a portion of actuator 340.

Any suitable method of attachment is considered suitable between acannula 370 and connecting member 374, and skilled artisans will be ableto select a suitable method of attachment according to a particularembodiment based on various considerations, including the materials thatform the cannula and/or connecting member. Example methods of attachmentconsidered suitable between a cannula and a connecting member include,but are not limited to, using an adhesive, fusing, and/or welding.Optionally, connecting member 374 can be omitted from medical device 310and support arm second end 398 can be pivotably attached directly tocannula 370.

While connecting member 374 has been described and illustrated aspositioned between the cannula proximal end 384 and the cannula distalend 386, a connecting member can be positioned at any suitable locationalong the length of a cannula. Skilled artisans will be able to select asuitable position for a connecting member according to a particularembodiment based on various considerations, including the structuralarrangement of the housing. Example locations considered suitable toposition a connecting member on a cannula include, but are not limitedto, positioning the connecting member on cannula distal end, andpositioning the connecting member between cannula proximal end andcannula distal end.

While the cannula proximal end 384 and connecting member proximal end400 have been illustrated as extending outside of housing cavity 344,the cannula and connecting member of a medical device can be positionedat any suitable location on a handle. Skilled artisans will be able toselect a suitable location to position a cannula and connecting memberof a medical device according to a particular embodiment based onvarious considerations, including the structural arrangement of thehousing. For example, alternative to positioning the cannula proximalend 384 and connecting member proximal end 400 outside of housing cavity344, a cannula proximal end and connecting member proximal end can bepositioned flush with the housing wall, or within the housing cavity. Itis considered advantageous to position the cannula proximal end 384outside of housing cavity 344, or flush with housing wall 342, at leastbecause this allows for one or more secondary devices to be passedthrough the cannula lumen 388.

Locking mechanism 376 is formed from a portion of housing 338 andcomprises a locking mechanism first end 410, a locking mechanism secondend 412, a locking mechanism exterior surface 414, and a lockingmechanism interior surface 416, and defines a locking mechanism firstprotuberance 418 and a plurality of locking mechanism secondprotuberances 420. Locking mechanism first end 410 is free of housing338 and locking mechanism second end 412 is pivotably attached tohousing 338. Locking mechanism first protuberance 418 is defined onlocking mechanism exterior surface 414 and extends outward and away fromhousing cavity 344. The plurality of locking mechanism secondprotuberances 420 is defined on locking mechanism interior surface 416and each protuberance of the plurality of protuberances extends inwardand towards housing cavity 344. In the illustrated embodiment, theplurality of locking mechanism second protuberances 420 is complementaryto the plurality of lever protuberances 394.

Locking mechanism 376 has a first position and a second position. In thefirst position, as shown in FIGS. 6, 6A, and 8, locking mechanism 376 isfree of lever 351. In the second position (not shown), locking mechanism376 is engaged with, or interacts with, lever 351 (e.g., plurality oflever protuberances). Locking mechanism 376 can be moved from the firstposition to the second position by applying a radially inward force onlocking mechanism first protuberance 418 such that locking mechanismfirst end 410 moves inward into, or towards, housing cavity 344. Thisresults in engagement of, or interaction between, the plurality oflocking mechanism second protuberances 420 and the plurality of leverprotuberances 394. In the second configuration, movement of lever 351within second opening 348 is prevented, or substantially prevented. Thisis considered advantageous at least because it provides a mechanism formaintaining the position of lever 351 when elongate member 312 hasdefined a desired radius of curvature 365. Thus, lever 351 is adapted tobe releasably fixed in the second position. The radius of curvature 365defined by elongate member 312 can be adjusted by removing the radiallyinward force on locking mechanism first protuberance 418 and adjustingthe position of lever 351 within second opening 348.

The inclusion of a locking mechanism 376 is considered advantageous atleast because it provides a mechanism to prevent, or substantiallyprevent, movement of wire member 316, lever 351, connecting member 374,and cannula 370, when a desired radius of curvature 365 has been definedby elongate member 312. For example, it is considered advantageous toinclude a locking mechanism 376 at least because it allows theconfiguration of elongate member 312 to be fixed, or substantiallyfixed, when treatment is being performed (e.g., dilation of a bodilypassage).

While locking mechanism 376 has been described and illustrated asproviding a structure capable of maintaining the position of lever 351in a second position, any suitable structural configuration capable ofmaintaining the position of an actuator (e.g., lever 351) is consideredsuitable for inclusion in a medical device. Skilled artisans will beable to select a suitable structural configuration to maintain theposition of an actuator according to a particular embodiment based onvarious considerations, including the structural arrangement of thehandle. In addition, while locking mechanism 376 has been described andillustrated as being formed from a portion of housing 338, a lockingmechanism can be a separate element, or combination of elements,attached to the housing, or other portion, of a medical device.

Housing wall 342 defines housing passageway 378 that extends from afirst passageway opening 422 on the exterior of housing 338 to a secondpassageway opening 424 in communication with the third lumen 366 ofelongate member 312. It is considered advantageous to include passageway378 to allow a user to pass one or more secondary devices through handle314 and elongate member 312 (e.g., chip-in-tip fiber optics).Optionally, passageway 378 can be omitted from medical device 312 ormore than one passageway can be defined by housing wall 342.Alternatively, multiple passageways can be defined by a housing suchthat each passageway is in communication with a lumen defined by anelongate member. This is considered advantageous at least because itprovides a mechanism for passing one or more secondary devices (e.g.,chip-in-tip fiber optics, illumination fibers, camera) through a handleand an elongate member.

In use, movement of lever 351 towards elongate member distal end 320, asshown by arrow 362, from the lever first position, as shown in FIGS. 6and 6A, to the lever second position, as shown in FIG. 8, causes wiremember 316 and support arm second end 398 to move in a proximal, orsubstantially proximal, direction. This results in cannula 370 beingmoved in the proximal direction within second lumen 328, tension in wiremember 316, and movement of elongate member 312 from a straight, orsubstantially straight, configuration, as shown in FIG. 6, to a curvedconfiguration, as shown in FIG. 8, in which elongate member 312 definescurve 364 at a radius of curvature 365. Movement of lever 351 towardsthe proximal end 384 of cannula 370, in a direction opposite that ofarrow 362, advances cannula 370 towards elongate member distal end 320within second lumen 328, reduces or eliminates tension in wire member316, and results in elongate member 312 returning to its straight, orsubstantially straight, configuration.

In the illustrated embodiment, cannula 370 is moveable between a cannulafirst position and a cannula second position. In the cannula firstposition, as illustrated in FIG. 6, cannula distal end 386 is positionedat a first location at, or near, elongate member distal end 320. It isconsidered advantageous to position cannula distal end 386 at, or near,elongate member distal end 320 at least because this provides rigidityto elongate member 312 during use (e.g., when it is desired to passmedical device 310 through a bodily passage). In the cannula secondposition, as illustrated in FIG. 8, as a result of lever 351 being beenmoved from its lever first position to its lever second position,cannula distal end 386 is positioned at a second location, which isproximal to the first location. Movement of cannula 370 from the cannulafirst position to the cannula second position is considered advantageousat least because it allows elongate member 312 to move between astraight, or substantially straight, configuration in which elongatemember 312 is rigid, or substantially rigid, to a curved configurationin which a portion of elongate member 312 is flexible, or substantiallyflexible.

Optionally cannula 370 can include an atraumatic tip on cannula distalend 386. It is considered advantageous to include an atraumatic tip onthe cannula distal end 386 at least because it decreases the likelihoodof wear and/or damage to elongate member 312 (e.g., lumen 328) whenelongate member 312 is moved between a first straight, or substantiallystraight, configuration and a curved configuration. Including anatraumatic tip can be accomplished using any suitable method and usingany suitable material, and skilled artisans will be able to select asuitable method of including an atraumatic tip and a suitable materialto form an atraumatic tip according to a particular embodiment based onvarious considerations, including the materials that form an elongatemember. Example methods of forming an atraumatic tip include, but arenot limited to, forming a cannula distal end of a soft and/or flexiblematerial, attaching a soft and/or flexible material to a cannula distalend, rounding a cannula distal end, perforating and/or cutting a cannuladistal end to provide flexibility (e.g., using a cutting tool such as alaser), and spraying a cannula distal end with a lubricious material.Example materials considered suitable to form an atraumatic tip include,but are not limited to, biocompatible materials, materials that can bemade biocompatible, polymers, metals, and any other material consideredsuitable for a particular application. For example, a polymer tip can beattached to a cannula distal end to reduce the likelihood of wear and/ordamage to an elongate member during use.

FIG. 9 illustrates an alternative cannula of a medical device. In theillustrated embodiment, cannula proximal end 384′ has a first cannuladiameter 385′ and cannula distal end 386′ has a second cannula diameter387′ that is less than first cannula diameter 385′. An atraumatic tip389′ is disposed on cannula distal end 386′. Atraumatic tip 389′comprises an atraumatic tip wall 428′, atraumatic tip proximal end 430′and an atraumatic tip distal end 432′. Atraumatic tip wall 428′ definesa tapered atraumatic tip distal end 432′ and an atraumatic tip aperture434′ that extends from an atraumatic tip first opening 436′ on theatraumatic tip proximal end 430′ to an atraumatic tip second opening438′ on the atraumatic tip distal end 432′. The atraumatic tip aperture434′ has an atraumatic tip first portion 440′ that extends fromatraumatic tip first opening 436′ towards atraumatic tip second opening438′ and an atraumatic tip second portion 442′ that extends fromatraumatic tip first portion 440′ to atraumatic tip second opening 438′.Atraumatic tip first portion 440′ has an atraumatic tip first diameter440″ and atraumatic tip second portion 442′ has an atraumatic tip seconddiameter 442″. Atraumatic tip first diameter 440″ is greater thanatraumatic tip second diameter 442″ and is equal to, substantially equalto, or less than, second cannula diameter 387′. This configuration isconsidered advantageous at least because it provides a friction fitbetween the atraumatic tip 389′ and cannula 370′. In addition, it isconsidered advantageous to form atraumatic tip first diameter 440″greater than atraumatic tip second diameter 442″ at least because thisforms atraumatic tip shoulder 444′ which provides a mechanical stop toadvancement of cannula 370′ through atraumatic tip 389′.

While atraumatic tip 389′ has been illustrated and described as beingattached to cannula distal end 386′ via friction fit, any suitablemethod of attachment between a cannula and an atraumatic tip can beused, and skilled artisans will be able to select a suitable method ofattachment between a cannula and an atraumatic tip according to aparticular embodiment based on various considerations, including thematerial forming the cannula and/or atraumatic tip. Example methods ofattachment considered suitable between a cannula and an atraumatic tipinclude, but are not limited to, fusing the atraumatic tip to thecannula (e.g., using heat), using an adhesive, and any other method ofattachment considered suitable for a particular application.

Any suitable secondary device can be passed through the lumen and/orpassageway of any of the medical devices described herein. For example,catheters, such as those described in co-pending application titled“Catheters and Methods for Identification and Treatment of BodilyPassages,” filed on Nov. 25, 2011, having application Ser. No.13/304,432, and hereby incorporated by reference into this disclosure inits entirety, can be used in combination with any of the medical devicesdescribed herein.

FIG. 10 illustrates an exemplary catheter 500 comprising an elongatemain body 502, a first balloon 504, and a second balloon 506.

Elongate main body 502 has a main body proximal end 508, a main bodydistal end 510, and defines a secondary device port 512, a firstinflation port 514, a second inflation port 516, a secondary devicelumen 518, a first inflation lumen 520, and a second inflation lumen522. Secondary device lumen 518 extends between a secondary device lumenfirst opening 526 in secondary device port 512 and a secondary devicelumen second opening 528 on main body distal end 510. First inflationlumen 520 extends between a first inflation lumen first opening 530 infirst inflation port 514 and a first inflation lumen second opening 532located between main body proximal end 508 and main body distal end 510.Second inflation lumen 522 extends between a second inflation lumenfirst opening 534 in second inflation port 516 and a second inflationlumen second opening 536 located between main body proximal end 508 andmain body distal end 510.

First balloon 504 is attached to main body distal end 510. The materialof first balloon 504 and the portion of the exterior surface of mainbody 502 positioned within first balloon 504 define a first ballooninflation chamber 538. First balloon 504 is positioned on main bodydistal end 510 such that first inflation lumen second opening 532 is incommunication with first balloon inflation chamber 538. With thisstructural arrangement, first balloon 504 is adapted to move between adeflated configuration and an inflated configuration as fluid is movedinto and out of first balloon inflation chamber 538 via first inflationlumen 520 and first inflation lumen first opening 530.

Second balloon 506 is attached to main body distal end 510 such that itsurrounds first balloon 504. The material of second balloon 506 and theportion of the exterior surface of main body 502 and the exteriorsurface of first balloon 504 define a second balloon inflation chamber540. Thus, first balloon 504 is disposed within second balloon inflationchamber 540. Second balloon 506 is positioned on main body distal end510 such that second inflation lumen second opening 536 is incommunication with second balloon inflation chamber 540. With thisstructural arrangement, second balloon 506 is adapted to move between adeflated configuration and an inflated configuration as fluid is movedinto and out of first balloon inflation chamber 538 and/or secondballoon inflation chamber 540. Thus, a user can expand second balloon506 either by inflating first balloon 504, inflating second balloon 506,or inflating both first balloon 504 and second balloon 506.

First balloon 504 can be moved from an inflated configuration to adeflated configuration by applying vacuum pressure to first inflationlumen 520 and removing the fluid disposed within first balloon inflationchamber 538. Second balloon 506 can be moved from an inflatedconfiguration to a deflated configuration by applying vacuum pressure tosecond inflation lumen 522 and removing the fluid disposed within secondballoon inflation chamber 540. FIG. 10 illustrates first balloon 504 andsecond balloon 506 in inflated configurations.

It is considered advantageous to provide a first balloon 504 and asecond balloon 506 at least because it allows for catheter 500 to havetwo different maximum diameters in the inflated configuration. Forexample, first balloon 504 can be advanced to an inflated configuration(e.g., a diameter of 5 mm) and second balloon 506 can be left deflated,or both first balloon 504 and second balloon 506 can be advanced to aninflated configuration providing a greater diameter (e.g., a diameter of7 mm) than that provided if only first balloon 504 was advanced to aninflated configuration. While particular inflated balloon diameters havebeen described, a balloon can be included that can achieve any suitableoutside diameter in the inflated configuration, and skilled artisanswill be able to select a suitable outside diameter for a balloonaccording to a particular embodiment based on various considerations,including the bodily passage intended to be treated. Example outsidediameters considered suitable for a balloon include, but are not limitedto, diameter between about 1 mm to about 10 mm. The inventors havedetermined that balloons having an inflated diameter between about 3 mmto about 10 mm are suitable. In addition, the inventors have determinedthat balloons having an inflated diameter about 7 mm are suitable.

In the illustrated embodiment, an optical fiber 542 is disposed throughsecondary device lumen 518. Optical fiber 542 extends between an opticalfiber proximal end 544 and an optical fiber distal end 546 and defines alight path extending through its length that allows axially-directedlight to emanate from optical fiber distal end 546. Optical fiberproximal end 544 is adapted to be operatively connected or attached to alight source 548. Optical fiber distal end 546 is free to move axiallythrough secondary device lumen 518 such that it can be disposed proximalto main body proximal end 508 or main body distal end 510, distal tomain body proximal end 508 or main body distal end 510, or disposed at,or near, main body proximal end 508 or main body distal end 510.

Any suitable optical fiber 542 can be used in combination with catheter500 and/or any of the medical device described herein, and skilledartisans will be able to select a suitable optical fiber according to aparticular embodiment based on various considerations, including thedesired bodily passage within which a medical device is intended to bedisposed. Example optical fibers considered suitable include, but arenot limited to, commercially available optical fibers such as plasticoptical fibers and glass optical fibers, with or without cladding.

Optical fiber 542 can have any suitable length, and skilled artisanswill be able to select a suitable length for an optical fiber accordingto a particular embodiment based on various considerations, the locationof the bodily passage intended to be identified and/or treated. Anexample length considered suitable includes, but is not limited to, alength that is greater than the length of catheter 500 and/or main body502.

Light source 548 is operatively connected or attached to optical fiberproximal end 544 and includes a fiber coupling 550 which providescommunication between the light source 548 and optical fiber 542. Lightgenerated by light source 548 travels through the light path defined byoptical fiber 542 and is emitted axially from optical fiber distal end546.

Any suitable light source 548 can be used, and skilled artisans will beable to select a suitable light source according to a particularembodiment based on various considerations, including the desired bodilypassage within which a medical device is intended to be used. Examplelight sources considered suitable include, but are not limited to,commercially-available light sources such as xenon, laser, LED, andhalogen light sources.

It is noted that while a single optical fiber 542 is described andillustrated, two or more different optical fibers can be used incombination, or independently, to provide axially-directed and/orradially directed light. The two optical fibers can extend through thesame or different lumens of an elongate main body 502 and can beoperatively connected or attached to the same or two different lightsources.

Additional structure can be attached to the catheters described hereinto facilitate the inflation and deflation of the balloon(s). Forexample, a syringe or other suitable structure can be attached to theinflation port(s) using any suitable connection, such as a luer lockconnection. The fluid used to inflate a balloon can be stored within thesyringe and/or inflation lumen(s) and can be introduced into and removedfrom the inflation chamber(s) by operating the syringe usingconventional practices.

FIG. 11 illustrates the exemplary catheter 500 and optical fiber 542illustrated in FIG. 10 disposed through cannula lumen 388 of medicaldevice 310. Elongate member 312 is illustrated in the first straight, orsubstantially straight, configuration and first balloon 504 and secondballoon 506 of catheter 500 are illustrated in an inflatedconfiguration.

In the illustrated embodiment, main body proximal end 508 is disposedproximal to cannula proximal end 384 and main body distal end 510 isdisposed distal to elongate member distal end 320. In addition, opticalfiber proximal end (not shown) is disposed proximal to main bodyproximal end 508 and optical fiber distal end 546 is disposed distal tomain body distal end 510.

While catheter 500 has been described and illustrated as disposedthrough cannula lumen 388 and optical fiber 542 has been described andillustrated as disposed through secondary device lumen 518, any suitabledevice can be passed through any lumen and/or passageway of a medicaldevice (e.g., second lumen 28, second lumen 128, third lumen 166, secondlumen 228, third lumen 266, third lumen 366, passageway 378, cannulalumen 388, secondary device lumen 518). Skilled artisans will be able toselect a suitable device to pass through a lumen and/or passageway of amedical device according to a particular embodiment based on variousconsiderations, including the desired procedure is intended to beperformed. Example devices considered suitable to pass through a lumenand/or passageway defined by a medical device include, but are notlimited to, catheters, balloon catheters, suction devices, graspers,cutting tools, illuminating members, optical fibers, cameras,chip-in-tip fiber optics, imaging devices, imaging fibers, and any otherdevice considered suitable for a particular application. Examples ofchip-in-tip fiber optics considered suitable include, but are notlimited to, an elongate member or fiber optic having a CCD image sensoror a CMOS image sensor disposed within or on the distal end of theelongate member or fiber optic. Thus, a secondary device can be selectedfrom the group of secondary devices described herein or from othersuitable groups of secondary devices.

Thus, a secondary device having a secondary device proximal end and asecondary device distal end can be passed through a lumen and/orpassageway of a medical device (e.g., medical device 10, medical device310, catheter 500, medical device 610, medical device 710), or portionthereof, such that the secondary device distal end is disposed proximalto, at, near, or distal to the distal end of the medical device. It isconsidered advantageous to advance a secondary device distal end to thedistal end of a medical device, such as those described herein, at leastbecause this allows for the secondary device to be introduced into abodily passage, such as a sinus cavity, to provide visualization of thebodily passage and/or treatment to the bodily passage.

For example, an imaging device, such as a scope comprising achip-in-tip, having a proximal end and a distal end, can be passedthrough passageway 378 to provide visualization during advancement ofmedical device 310 through a bodily passage and/or during treatment ofthe bodily passage. Any suitable imaging device can be used incombination with any of the medical devices described herein, andskilled artisans will be able to select a suitable device according to aparticular embodiment based on various considerations, including thedesired bodily passage within which a medical device is intended to beused. An example imaging device considered suitable includes, but is notlimited to, an eyeMAX (eyeMAX is a registered trademark of Richard WolfGmbH Corporation of Knittlingen, Federal Republic of Germany) endoscopewith chip on-the-tip, or chip-in-tip, technology.

While various devices have been described as being passed through alumen and/or passageway of a medical device (e.g., second lumen 28,second lumen 128, third lumen 166, second lumen 228, third lumen 266,third lumen 366, passageway 378, cannula lumen 388, secondary devicelumen 518), one or more devices can be embedded within the wall of anelongate member of a medical device, or attached to a portion of amedical device (e.g., elongate member). Skilled artisans will be able toselect a suitable device to embed within the wall of an elongate memberaccording to a particular embodiment based on various considerations,including the desired procedure intended to be performed. Example numberof devices considered suitable to embed within the wall of an elongatemember of a medical device include, but are not limited to, one, atleast one, two, a plurality, three, four, and any other numberconsidered suitable for a particular application. Example devicesconsidered suitable to embed within the wall of an elongate member of amedical device include, but are not limited to, illuminating members,optical fibers, cameras, chip-in-tip fiber optics, imaging devices,imaging fibers, and any other device considered suitable for aparticular application. For example, the wall of an elongate member caninclude one or more embedded optical fibers and/or one or more imagingdevices to provide illumination and/or imaging during advancement of themedical device through a bodily passage and/or during treatment of thebodily passage.

When an imaging device, such as a camera, is disposed through, attached,or embedded within, a portion of a medical device, such as thosedescribed herein, the imaging device can be adapted to capture imagesfrom the distal end of the medical device and/or from the circumferenceof the medical device at any point along the medical device length. Theimaging device can be adapted to be attached to a display and/or powersource and to provide still and/or live footage to the display forreview by a user. Alternatively, multiple imaging devices can be used inconjunction with, or separate from, one another. An imaging device cancomprise a wired and/or wireless camera or chip that is adapted totransmit images to a display and/or storage device.

FIGS. 12 and 12A illustrate another exemplary medical device 610.Medical device 610 is similar to medical device 10 illustrated in FIGS.1, 1A, 2, and 3, and described above, except as detailed below.Reference numbers in FIGS. 12 and 12A refer to the same structuralelement or feature referenced by the same number in FIGS. 1, 1A, 2, and3, offset by 600. Thus, medical device 610 comprises an elongate member612, a handle 614, and a wire member 616.

In the illustrated embodiment, handle 614 is disposed along the lengthof elongate member 612 between elongate member proximal end 618 andelongate member distal end 620 and comprises a handle proximal end 635,a handle distal end 637, a housing 638, and an actuator 640 (e.g., lever651). Housing 638 has a housing wall 642 that defines a housing cavity644, a first housing opening 646, a second housing opening 648, and athird housing opening 650. Each of the first housing opening 646, secondhousing opening 648, and third housing opening 650 extends through thehousing wall 642 and provides access to housing cavity 644.

In the illustrated embodiment, actuator 640 comprises lever 651 having alever first end 652, lever second end 654, and a wall 653 that definesan opening 655, a first aperture 657, and attachment apertures 659. Eachof the opening 655, first aperture 657, and attachment apertures 659extends through the wall 653 of lever 651. Lever first end 652 isdisposed within the housing cavity 644 and lever second end 654 isdisposed outside of housing cavity 644. Opening 655 is defined on lever651 between lever first end 652 and lever second end 654 and is adaptedto receive a portion of elongate member 612. Thus, elongate member 612is disposed through opening 655. First aperture 657 is defined on lever651 between opening 655 and lever first end 652 and is adapted toreceive a portion of wire member 616.

Each attachment aperture 659 is adapted to receive a portion of a pin656 to pivotably attach lever 651 to housing wall 642 such that lever651 can move within second housing opening 648 between a lever firstposition and a lever second position. Movement of lever 651 between thelever first position and the lever second position results in movementof elongate member 612 between a first straight, or substantiallystraight, configuration, and a curved configuration.

While pins 656 have been illustrated and described as providingpivotable attachment between lever 651 and housing 638, any suitablemethod of attachment between an actuator (e.g., lever) and a housing canbe used. Skilled artisans will be able to select a suitable method ofattachment between an actuator and a housing according to a particularembodiment based on various considerations, including the materialsforming the actuator and the housing. An example method of attachmentconsidered suitable between an actuator and a housing includes, but isnot limited to, using a threaded attachment device (e.g., screw), ashaft, and any other method of attachment considered suitable for aparticular application.

In the illustrated embodiment, wire member 616 comprises a wire memberfirst end 658 and a wire member second end (not shown). Wire memberfirst end 658 is attached to lever 651 between lever first end 652 andlever second end 654 by passing wire member 616 through first aperture657 and wrapping wire member 616 around lever 651, as described herein.

While wire member first end 658 has been described and illustrated asbeing passed through first aperture 657, a wire member can be connectedto a lever and/or actuator using any suitable method of attachment, andskilled artisans will be able to select a suitable method of attachmentbetween a wire member and a lever and/or actuator according to aparticular embodiment based on various considerations, including thematerials forming the wire member and the lever and/or actuator. Examplemethods of attachment are described herein.

FIGS. 13, 14, and 14A illustrate another exemplary medical device 710.Medical device 710 is similar to medical device 310 illustrated in FIGS.6, 6A, 7, and 8, and described above, except as detailed below.Reference numbers in FIGS. 13, 14, and 14A refer to the same structuralelement or feature referenced by the same number in FIGS. 6, 6A, 7, and8, offset by 400. Thus, medical device 710 comprises an elongate member712, a handle 714, and a wire member 716.

In the illustrated embodiment, medical device 710 comprises a cannula770 that is partially disposed through elongate member 712 and handle714. Handle 714 comprises an actuator 740 and a locking mechanism 776.Actuator 740 comprises a lever 751, a support arm 772, and a connectingmember 774. Handle 714 omits the inclusion of a passageway (e.g.,passageway 378 illustrated in FIGS. 6, 6A, and 8). Housing 738 isdisposed within opening 842 defined by the wall 836 of lever 751, asdescribed below. While handle 714 omits the inclusion of a passageway,any suitable number of passageways can be included in a handle, andskilled artisans will be able to select a suitable number of passagewaysto include in a handle according to a particular embodiment based onvarious considerations, including the number of lumens defined by anelongate member. Example number of passageways considered suitable toinclude in a handle include, but are not limited to, one, at least one,two, a plurality, three, four, and any other number considered suitablefor a particular application.

In the illustrated embodiment, handle 714 is disposed on elongate memberproximal end 718 such that elongate member proximal end 718 ispositioned within housing cavity 744. This is considered advantageous atleast because it provides stability of medical device 710 during use andlimits the devices and/or structures positioned proximal to handle 714.Cannula 770 is slidingly disposed through a portion of housing 738 and aportion of elongate member 712. Cannula 770 is slidingly disposedthrough housing first opening 746 such that the cannula proximal end 784is disposed proximal to housing 738 and outside of housing cavity 744.

In the illustrated embodiment, lever 751 has a lever first end 752, alever second end 754, a first lever arm 830, a second lever arm 832, athird lever arm 834 and a lever wall 836 that defines attachmentapertures 838, first aperture 840, opening 842, and lever protuberance844. Each of the first lever arm 830 and second lever arm 832 extendsfrom the lever first end 752 to the lever second end 754 and ispivotably attached to housing wall 742 by pins 756. Third lever arm 834extends between first lever arm 830, second lever arm 832, and intohousing second opening 748 and is adapted to be attached to wire member716. Each attachment aperture 838 is disposed between the lever firstend 752 and lever second end 754 and first aperture 840 is disposedbetween lever second end 754 and attachment apertures 838. A first pin756 is disposed through a first attachment aperture 838 and a second pin756 is disposed through a second attachment aperture 838. Leverprotuberance 844 extends radially inward into opening 842 and isdisposed between first lever arm 830 and second lever arm 832 on leverfirst end 752. Alternatively, lever protuberance 844 can extend fromfirst lever arm 830 to second lever arm 832. Housing 738 is disposedwithin opening 842 and lever 751 is adapted to move with respect tohousing 738 between a lever first position and a lever second position,as described in more detail herein.

Support arm 772 has a support arm first end 796 and a support arm secondend 798. Support arm first end 796 is pivotably attached to lever secondend 754 by pin 797 that extends through an aperture defined by the wallof support arm 772 and support arm second end 798 is pivotably attachedto connecting member 774 by pin 799 that extends through an aperturedefined by the wall of support arm. Alternatively, support arm secondend 798 can be pivotably attached to cannula 770. Connecting member 774has a connecting member proximal end 800, a connecting member distal end802, and defines a connecting member lumen 804 that extends from a firstconnecting member opening on connecting member proximal end 800 to asecond connecting member opening on connecting member distal end 802.Connecting member 774 is attached to cannula 770 between the cannulaproximal end 784 and cannula distal end 786.

In the illustrated embodiment, first lever arm 830, second lever arm832, support arm 772, and connecting member 774 are disposed outside ofhousing 738 (e.g., not in housing cavity 744). This configuration isconsidered advantageous at least because it reduces the structuralfeatures within housing cavity 744.

Locking mechanism 776 is formed from a portion of housing 738 andcomprises a locking mechanism first end 810, a locking mechanism secondend 812, a locking mechanism exterior surface 814, a locking mechanisminterior surface 816, and defines a locking mechanism first protuberance818 and a plurality of locking mechanism second protuberances 820.Locking mechanism first end 810 is free of housing 738 and lockingmechanism second end 812 is pivotably attached to housing 738. Lockingmechanism first protuberance 818 is defined on the exterior surface 814of locking mechanism 776 and extends outward and away from housingcavity 744. Each protuberance of the plurality of locking mechanismsecond protuberances 820 is defined on the exterior surface 814 oflocking mechanism 776 and extends outward and away from the housingcavity 744. In the illustrated embodiment, the plurality of lockingmechanism second protuberances 820 is complementary to protuberance 844defined by lever 751.

Locking mechanism 776 has a locking mechanism first position and alocking mechanism second position. In the locking mechanism firstposition, locking mechanism 776 is engaged with, or interacts with,lever protuberance 844 such that movement of lever 751 is prevented, orsubstantially prevented. As lever 751 is moved along the wall 742 ofhousing 738 its position is maintained by locking mechanism 776. Thus,the housing 738 and lever 751 are structurally arranged such thatlocking mechanism 776 and lever 751 are engaged, or interacting, withone another without the application of outside forces. In the lockingmechanism second position, locking mechanism 776 is free of lever 751such that lever 751 can be moved between its lever first position andlever second position. Locking mechanism 776 can be moved from thelocking mechanism first position to the locking mechanism secondposition by applying a radially inward force on locking mechanismprotuberance 818 such that locking mechanism first end 810 moves inwardinto, or towards, housing cavity 744. This results in disengagement ofthe plurality of locking mechanism second protuberances 820 and leverprotuberance 844. This is considered advantageous at least because itprovides a mechanism for maintaining the position of lever 751 whenelongate member 712 has defined a desired radius of curvature. Thus,lever 751 is adapted to be releasably fixed in the lever second positionuntil additional forced is placed on lever 751 to move it along the wall742 of housing 738 or additional force is placed on locking mechanism776 to free lever 751 of locking mechanism 776.

The inclusion of a locking mechanism 776 is considered advantageous atleast because it provides a mechanism to prevent, or substantiallyprevent, movement of wire member 716, lever 751, connecting member 774,and cannula 770, when a desired radius of curvature has been defined byelongate member 712. For example, it is considered advantageous toinclude a locking mechanism 776 at least because it allows theconfiguration of elongate member 712 to be fixed, or substantiallyfixed, when treatment is being performed (e.g., dilation of a bodilypassage).

In use, movement of lever first end 752 away from cannula proximal end784, as shown by arrow 762, from the lever first position to the leversecond position causes wire member 716 and support arm second end 798 tomove in a proximal, or substantially proximal, direction. This resultsin cannula 770 being moved in the proximal direction, tension in wiremember 716, and movement of elongate member 712 from a straight, orsubstantially straight, configuration, to a curved configuration inwhich elongate member 712 defines a curve. Movement of lever first end752 towards cannula proximal end 784, in a direction opposite, orsubstantially opposite, that of arrow 762, advances cannula 770 towardselongate member distal end, reduces, or eliminates, tension in wiremember 716, and results in elongate member 712 returning to itsstraight, or substantially straight, configuration.

Various methods of treatment are described herein. While the methodsdescribed herein are shown and described as a series of acts, it is tobe understood and appreciated that the methods are not limited by theorder of acts, as some acts may in accordance with these methods, occurin different orders, and/or concurrently with other acts describedherein.

FIG. 18 is a flowchart representation of a method 900 of treating tissuein a bodily passage defined by a bodily passage wall.

A step 902 comprises introducing a first medical device having a firstproximal end and a first distal end into the bodily passage such thatthe first distal end is disposed within the bodily passage. The firstmedical device comprises an elongate member, a handle, and a wiremember. The elongate member has an elongate member proximal end, anelongate member distal end, and defines a first lumen and a secondlumen. The handle is disposed on the elongate member and has an actuatormoveable between an actuator first position and an actuator secondposition. The actuator comprises a first portion and a second portion.The wire member is partially disposed within the first lumen and has awire member first end attached to the first portion of the actuator anda wire member second end attached to the elongate member. The elongatemember is moveable between a substantially straight configuration whenthe actuator is in the actuator first position and a curvedconfiguration when the actuator is in the actuator second position.Another step 904 comprises advancing the first medical device into thebodily passage such that the first distal end is disposed adjacent apoint of treatment. Another step 906 comprises advancing the actuator ofthe first medical device from the actuator first position to theactuator second position such that the elongate member moves from thesubstantially straight configuration to the curved configuration.Another step 908 comprises introducing a second medical device having asecond proximal end and a second distal end into the second lumendefined by the first medical device such that the second distal end isdisposed with the second lumen. Another step 910 comprises advancing thesecond medical device through the second lumen defined by the firstmedical device such that the second distal end is disposed distal to thefirst distal end. Another step 912 comprises providing treatment usingthe second medical device. Another step 914 comprises stopping the stepof providing treatment using the second medical device. Another step 916comprises withdrawing the second medical device from the second lumendefined by the first medical device such that the second distal end isdisposed proximal to the first proximal end. Another step 918 comprisesadvancing the actuator of the first medical device from the actuatorsecond position to the actuator first position. Another step 920comprises withdrawing the first medical device from the bodily passagesuch that the first distal end is disposed outside of the bodilypassage.

Step 902 can be accomplished using any suitable medical device accordingto an embodiment, such as the embodiments described and illustratedherein. Skilled artisans will be able to select a suitable medicaldevice to introduce into a bodily passage according to a particularembodiment based on various considerations, including the treatmentintended to be performed. Examples of medical devices consideredsuitable to introduce into a bodily passage to complete one or moresteps and/or methods described herein include, but are not limited to,medical device 10, medical device 310, medical device 610, medial device710, medical devices that include an elongate member according to anembodiment (e.g., elongate member 112, elongate member 212), medicaldevices that include a cannula according to an embodiment (e.g., cannula370′), and any other medical device considered suitable for a particularapplication.

Step 902 can be accomplished by applying a distally-directed force onany suitable portion of the first medical device (e.g., handle) suchthat the first distal end is disposed within the bodily passage. Step902 can be accomplished by introducing the first medical device into anysuitable bodily passage. Skilled artisans will be able to select asuitable bodily passage to introduce a medical device according to aparticular embodiment based on various considerations, including thetreatment intended to be performed. Example bodily passages consideredsuitable to introduce a medical device include, but are not limited to,a sinus passage, a sinus cavity, and any other bodily passage consideredsuitable for a particular application.

Step 904 can be accomplished by applying a distally-directed force onany suitable portion of the first medical device (e.g., handle) suchthat the first distal end is advanced into the bodily passage and isdisposed adjacent a point of treatment. Alternatively, the first distalend of a medical device can be advanced into a bodily passage such thatit is disposed at, near, proximal to, distal to, or at any othersuitable position relative to a point of treatment.

Step 906 can be accomplished by applying either a proximally-directedforce or a distally-directed force on an actuator such that it isadvanced from the actuator first position to the actuator secondposition and the elongate member moves from the substantially straightconfiguration to the curved configuration. The directionality of theforce will depend on the structural arrangement of the handle andactuator of the first medical device. For example, with respect tomedical device 10, a proximally-directed force can be applied theactuator to advance the actuator from the actuator first position to theactuator second position. Alternatively, with respect to medical device310, a distally-directed force can be applied to the actuator to advancethe actuator from the actuator first position to the actuator secondposition.

Alternative to completing step 906, a step that comprises advancing theactuator from the actuator first position to a position between theactuator first position and the actuator second position can becompleted such that the elongate member moves from the substantiallystraight configuration to the curved configuration. For example, thisstep can be completed to achieve a radius of curvature that is greaterthan the radius of curvature when the actuator is in the actuator secondposition.

An optional step comprises applying torque to any suitable portion ofthe first medical device (e.g., handle) such that the first medicaldevice is rotated and the first distal end is directed towards the pointof treatment, or an opening defined by the bodily passage wall.

Another optional step comprises advancing the first distal end of thefirst medical device towards the bodily passage wall, or an openingdefined by the bodily passage wall (e.g., sinus passage, sinus cavity,ostium). This step can be accomplished by applying a force on anysuitable portion of the first medical device (e.g., handle) in adirection such that the first distal end is advanced towards the bodilypassage wall, or an opening defined by the bodily passage wall (e.g., ina direction that extends on an axis that passes through the longitudinalaxis of the first medical device).

Another optional step comprises introducing the first distal end of thefirst medical device into an opening defined by the bodily passage wall.This step can be accomplished by applying a force on any suitableportion of the first medical device (e.g., handle) in a direction suchthat the first distal end is introduced into the opening defined by thebodily passage (e.g., in a direction that extends on an axis that passesthrough the longitudinal axis of the first medical device). Optionally,the first distal end can be advanced through the opening defined by thebodily passage wall and into another bodily passage (e.g., sinuspassage, sinus cavity).

Another optional step comprises maintaining the position of the actuatorwhen the actuator is in the actuator second position, or in a positionbetween the actuator first position and the actuator second position. Inembodiments that include a locking mechanism, this step can beaccomplished by activating the locking mechanism (e.g., by applying aradially inward force on a portion of a locking mechanism) to maintainthe radius of curvature defined by the elongate member when the actuatoris in the actuator second position, or in a position between theactuator first position and the actuator second position. Alternatively,this step can be accomplished by applying a force on the actuator (e.g.,radially inward force, proximally-directed force, distally-directed)such that the radius of curvature defined by the elongate member ismaintained when the actuator is in the actuator second position, or in aposition between the actuator first position and the actuator secondposition.

Step 908 can be accomplished using any suitable medical device, such asthe embodiments described and illustrated herein. Skilled artisans willbe able to select a suitable second medical device to introduce into afirst medical device according to a particular embodiment based onvarious considerations, including the treatment intended to beperformed. Examples of medical devices considered suitable to introduceinto a first medical device to complete one or more steps and/or methodsdescribed herein include, but are not limited to, catheters, catheter500, balloon catheters, suction devices, graspers, cutting tools,illuminating members, optical fibers, cameras, scopes, chip-in-tip fiberoptics, imaging devices, imaging fibers, and any other medical deviceconsidered suitable for a particular application. Alternative to passinga second medical device through a first medical device, a second medicaldevice can be preloaded within a lumen defined by an elongate member ofa first medical device such that step 908 can be omitted.

Step 908 can be accomplished by applying a distally-directed force onany suitable portion of the second medical device such that the seconddistal end of the second medical device is disposed within the secondlumen defined by the elongate member of the first medical device.

Step 910 can be accomplished by applying a distally-directed force onany suitable portion of the second medical device such that the secondmedical device is advanced through the second lumen and the seconddistal end is disposed distal to the first distal end. For example, thisstep can be accomplished such that the second distal end is disposed at,near, adjacent, proximal to, or distal to a point of treatment.

An optional step comprises advancing the second distal end towards thebodily passage wall, or an opening defined by the bodily passage wall(e.g., sinus passage, ostium). This step can be accomplished by applyinga distally-directed force on any suitable portion of the second medicaldevice such that the second distal end is advanced towards the bodilypassage wall, or the opening defined by the bodily passage wall. Thisoptional step can be completed subsequent to step 906 such that thesecond distal end is directed towards a desired point of treatment as itis advanced.

Another optional step comprises introducing the second distal end of thesecond medical device into an opening defined by the bodily passagewall. This step can be accomplished by applying a distally-directedforce on any suitable portion of the second medical device in adirection such that the second distal end is introduced into the openingdefined by the bodily passage. Optionally, the second distal end can beadvanced through the opening defined by the bodily passage wall and intoanother bodily passage (e.g., sinus passage, sinus cavity).

For example, the second medical device can comprise an imaging device,such as a scope, and can include chip-in-tip fiber optic, a proximal endand a distal end. The imaging device can be passed through the secondlumen of the first medical device and/or advanced through an openingdefined by the bodily passage wall (e.g., ostium) and into a secondbodily passage (e.g., sinus cavity) to provide visualization duringadvancement of the first and/or second medical device through a bodilypassage and/or during treatment. Any suitable imaging device can be usedin combination with any of the medical devices described herein, andskilled artisans will be able to select a suitable imaging deviceaccording to a particular embodiment based on various considerations,including the desired bodily passage within which a medical device isintended to be used. Optional steps include activating the imagingdevice and deactivating the imaging device.

Step 912 can be accomplished using conventional techniques and willdepend on the medical device that has been advanced through the secondlumen of the first medical device. For example, if a catheter, such ascatheter 500, has been passed through the second lumen, the step ofproviding treatment can include a step that comprises activating thelight source such that light is emitted axially from the optical fiber,and/or a step of introducing a fluid into the first balloon such thatthe first balloon is moved from the deflated configuration to theinflated configuration, and/or a step of introducing a fluid into thesecond balloon such that the second balloon is moved from the deflatedconfiguration to the inflated configuration.

Step 914 can be accomplished using convention techniques and will dependon the medical device that has been advanced through the second lumen ofthe first medical device. For example, if a catheter, such as catheter500, has been passed through the second lumen, the step of stopping thestep of providing treatment can include a step that comprisesdeactivating the light source such that light is not emitted axiallyfrom the optical fiber, and/or a step of removing a portion, or theentirety, of the fluid disposed within the first balloon to move thefirst balloon from the inflated configuration to the deflatedconfiguration, and/or a step of removing a portion, or the entirety, ofthe fluid disposed within the second balloon to move the second balloonfrom the inflated configuration to the deflated configuration.

In embodiments in which the elongate member of the first medial devicedefines more than two lumens (e.g., a third lumen), an optional stepcomprises introducing a third medical device having a third proximal endand a third distal end into the third lumen such that the third distalend is disposed within the third lumen. Another optional step comprisesadvancing third medical device through the third lumen such that thethird distal end is disposed distal to the first distal end. Anotheroptional step comprises providing treatment using the third medicaldevice. Another optional step comprises stopping the step of providingtreatment using the third medical device. Another optional stepcomprises withdrawing the third medical device from the third lumen suchthat the third distal end is disposed proximal to the first proximalend. Examples of suitable medical devices considered suitable tocomplete these optional step are described above with respect to step908 and herein. In addition, examples of completing one or more of theseoptional steps are described herein with respect to the second medicaldevice.

Step 916 can be accomplished by applying a proximally-directed force onany suitable portion of the second medical device until it has beenwithdrawn from the first medical device and such that the second distalend is disposed proximal to the first proximal end. Optionally, step 916can be omitted from method 900.

Step 918 can be accomplished by applying either a proximally-directedforce or a distally-directed force on an actuator such that it isadvanced from the actuator second position to the actuator firstposition and the elongate member moves from the curved configuration tothe substantially straight configuration. The directionality of theforce will depend on the structural arrangement of the handle andactuator of the first medical device. For example, with respect tomedical device 10, a distally-directed force can be applied the actuatorto advance the actuator from the actuator second position to theactuator first position. Alternatively, with respect to medical device310, a proximally-directed force can be applied to the actuator toadvance the actuator from the actuator first position to the actuatorsecond position. Optionally, step 918 can be omitted from method 900.

Step 920 can be accomplished by applying a proximally-directed force onany suitable portion of the first medical device (e.g., handle) until ithas been withdrawn from the bodily passage and such that the firstdistal end of the first medical device is disposed proximal to andoutside of the bodily passage.

While step 916, step 918, and step 920 have been described as separatesteps, step 916, step 918, and/or step 920 can be completed incombination with one another.

While various steps, alternative steps, and optional steps have beendescribed above with respect to method 900, these steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methods, steps,alternative steps, and/or optional steps described below with respectmethod 1000.

FIG. 19 is a flowchart representation of a method 1000 of treatingtissue in a bodily passage wall. The bodily passage wall defines abodily passage and an opening.

A step 1002 comprises introducing a first medical device having a firstproximal end and a first distal end into the bodily passage such thatthe first distal end is disposed within the bodily passage. The firstmedical device comprises an elongate member, a handle, a wire member,and a cannula. The elongate member has an elongate member proximal end,an elongate member distal end, and defines a first lumen and a secondlumen. The handle is disposed on the elongate member and has an actuatormoveable between an actuator first position and an actuator secondposition. The actuator comprises a first portion and a second portion.The wire member has a wire member first end attached to the firstportion of the actuator and a wire member second end attached to theelongate member. The cannula has a cannula proximal end attached to thesecond portion of the actuator and a cannula distal end disposed withinthe second lumen and defines a cannula lumen. The cannula is moveablebetween a cannula first position when the actuator is in the actuatorfirst position and a cannula second position when the actuator is in theactuator second position. In the cannula first position the cannuladistal end is disposed at a first location within the second lumen. Inthe cannula second position the cannula distal end is disposed at asecond location in the second lumen that is proximal to the firstlocation. The elongate member is moveable between a substantiallystraight configuration when the actuator is in the actuator firstposition and a curved configuration when the actuator is in the actuatorsecond position. Another step 1004 comprises advancing the first medicaldevice into the bodily passage such that the first distal end isdisposed adjacent a point of treatment. Another step 1006 comprisesadvancing the actuator of the first medical device from the actuatorfirst position to the actuator second position such that the cannulamoves from the cannula first position to the cannula second position andthe elongate member moves from the substantially straight configurationto the curved configuration. Another step 1008 comprises applying torqueto the first medical device such that the first distal end is directedtowards the opening defined by the bodily passage wall. Another step1010 comprises advancing the first distal end towards the openingdefined by the bodily passage wall. Another step 1012 comprisesintroducing the first distal end of the first medical device into theopening defined by the bodily passage wall. Another step 1014 comprisesintroducing a second medical device having a second proximal end and asecond distal end into the cannula lumen such that the second distal endis disposed with the cannula lumen. Another step 1016 comprisesadvancing the second medical device through the cannula lumen such thatthe second distal end is disposed distal to the first distal end.Another step 1018 comprises providing treatment using the second medicaldevice. Another step 1020 comprises stopping the step of providingtreatment using the second medical device. Another step 1022 compriseswithdrawing the second medical device from the cannula lumen such thatthe second distal end is disposed proximal to the first proximal end.Another step 1024 comprises withdrawing the first distal end from theopening defined by the bodily passage wall. Another step 1026 comprisesadvancing the actuator of the first medical device from the actuatorsecond position to the actuator first position. Another step 1028comprises withdrawing the first medical device from the bodily passagesuch that the first distal end is disposed outside of the bodilypassage.

Step 1002 can be accomplished using any suitable medical deviceaccording to an embodiment, such as the embodiments described andillustrated herein. Skilled artisans will be able to select a suitablemedical device to introduce into a bodily passage according to aparticular embodiment based on various considerations, including thetreatment intended to be performed. Examples of medical devicesconsidered suitable to introduce into a bodily passage to complete oneor more steps and/or methods described herein include, but are notlimited medical device 310, medial device 710, medical devices thatinclude an elongate member according to an embodiment (e.g., elongatemember 112, elongate member 212), medical devices that include a cannulaaccording to an embodiment (e.g., cannula 370′), and any other medicaldevice considered suitable for a particular application.

Step 1002 can be accomplished as described above with respect to step902 and by introducing the first medical device into any suitable bodilypassage. Skilled artisans will be able to select a suitable bodilypassage to introduce a medical device according to a particularembodiment based on various considerations, including the treatmentintended to be performed. Example bodily passages considered suitable tointroduce a medical device include, but are not limited to, a sinuspassage, a sinus cavity, and any other bodily passage consideredsuitable for a particular application.

Step 1004 can be accomplished as described above with respect to step904 and the alternatives described relative to step 904. For example,step 1004 can be accomplished such that first distal end is disposedadjacent the opening defined by said bodily passage wall.

Step 1006 can be accomplished as described above with respect to step906 and the alternatives described relative to step 906 and such thatthe cannula moves from the first position to the second position and theelongate member moves from the substantially straight configuration tothe curved configuration. For example, with respect to medical device310, a distally-directed force can be applied the actuator to advancethe actuator from the actuator first position to the actuator secondposition. Alternatively, with respect to medical device 710, aproximally-directed force can be applied to the actuator to advance theactuator from the actuator first position to the actuator secondposition.

Step 1008 can be accomplished by applying torque to any suitable portionof the first medical device (e.g., handle) such that the first medicaldevice is rotated and the first distal end is directed towards theopening (e.g., ostium) defined by the bodily passage wall.

Step 1010 can be accomplished by applying a force on any suitableportion of the first medical device (e.g., handle) in a direction suchthat the first distal end is advanced towards the opening defined by thebodily passage wall (e.g., in a direction that extends on an axis thatpasses through the longitudinal axis of the first medical device) andthe first distal end is disposed within, or beyond, the opening definedby the bodily passage wall.

Step 1012 can be accomplished by applying a force on any suitableportion of the first medical device (e.g., handle) in a direction suchthat the first distal end is introduced into the opening defined by thebodily passage (e.g., in a direction that extends on an axis that passesthrough the longitudinal axis of the first medical device). Optionally,the first distal end can be advanced through the opening defined by thebodily passage wall and into another bodily passage (e.g., sinuspassage, sinus cavity).

An optional step comprises maintaining the position of the actuator whenthe actuator is in the actuator second position, or in a positionbetween the actuator first position and the actuator second position. Inembodiments that include a locking mechanism, this step can beaccomplished by activating the locking mechanism (e.g., by applying aradially inward force on a portion of a locking mechanism) to maintainthe position of the cannula and the radius of curvature defined by theelongate member when the actuator is in the actuator second position, orin a position between the actuator first position and the actuatorsecond position. Alternatively, this step can be accomplished byapplying a force on the actuator (e.g., radially inward force,proximally-directed force, distally-directed) such that the position ofthe cannula and the radius of curvature defined by the elongate memberis maintained when the actuator is in the actuator second position, orin a position between the actuator first position and the actuatorsecond position.

Step 1014 can be accomplished using any suitable medical device, such asthe embodiments described and illustrated herein. Skilled artisans willbe able to select a suitable second medical device to introduce into afirst medical device according to a particular embodiment based onvarious considerations, including the treatment intended to beperformed. Examples of medical devices considered suitable to introduceinto a first medical device are described above with respect to method900 and herein. Alternative to passing a second medical device through afirst medical device, a second medical device can be preloaded within alumen defined by an elongate member of a first medical device such thatstep 1014 can be omitted.

Step 1014 can be accomplished by applying a distally-directed force onany suitable portion of the second medical device such that the seconddistal end of the second medical device is disposed within the cannulalumen.

Step 1016 can be accomplished by applying a distally-directed force onany suitable portion of the second medical device such that the secondmedical device is advanced through the cannula lumen and the seconddistal end is disposed distal to the first distal end. This step can beaccomplished such that the second distal end is disposed at, near,adjacent, proximal to, or distal to a point of treatment.

An optional step comprises advancing the second distal end towards theopening defined by the bodily passage wall (e.g., sinus passage,ostium). This step can be accomplished by applying a distally-directedforce on any suitable portion of the second medical device such that thesecond distal end is advanced towards the opening defined by the bodilypassage wall.

Another optional step comprises introducing the second distal end of thesecond medical device into the opening defined by the bodily passagewall. This step can be accomplished by applying a distally-directedforce on any suitable portion of the second medical device in adirection such that the second distal end is introduced into the openingdefined by the bodily passage. Optionally, the second distal end can beadvanced through the opening defined by the bodily passage wall and intoanother bodily passage (e.g., sinus passage, sinus cavity).

For example, the second medical device can comprises an imaging device,such as a scope, and can include chip-in-tip fiber optic, a proximal endand a distal end. The imaging device can be passed through the cannulalumen of the first medical device and/or advanced through the openingdefined by the bodily passage wall (e.g., ostium) and into a secondbodily passage (e.g., sinus cavity) to provide visualization duringadvancement of the first and/or second medical device through a bodilypassage and/or during treatment. Any suitable imaging device can be usedin combination with any of the medical devices described herein, andskilled artisans will be able to select a suitable imaging deviceaccording to a particular embodiment based on various considerations,including the desired bodily passage within which a medical device isintended to be used. When an imaging device has been advanced throughthe cannula lumen, the optional steps described above can beaccomplished such that the second distal end of the imaging device isdisposed past the opening defined by the bodily passage wall (e.g.,ostium) and into a second bodily passage (e.g., sinus cavity). Optionalsteps include activating the imaging device and deactivating the imagingdevice.

Step 1018 can be accomplished using conventional techniques and willdepend on the medical device that has been advanced through the cannulalumen. For example, step 1018 can be accomplished as described abovewith respect to step 912.

Step 1020 can be accomplished using conventional techniques and willdepend on the medical device that has been advanced through the cannulalumen. For example, step 1020 can be accomplished as described abovewith respect to step 914.

Step 1022 can be accomplished as described above with respect to step916. Optionally, step 1022 can be omitted from method 1000.

Step 1024 can be accomplished by applying a force on any suitableportion of the first medical device (e.g., handle) in a direction suchthat the first distal end is withdrawn from the opening defined by thebodily passage wall (e.g., in a direction that extends on an axis thatpasses through the longitudinal axis of the first medical device).

Step 1026 can be accomplished as described above with respect to step918 and the alternatives described relative to step 918 and such thatthe cannula moves from the second position to the first position and theelongate member moves from the curved configuration to the substantiallystraight configuration. For example, with respect to medical device 310,a proximally-directed force can be applied the actuator to advance theactuator from the actuator second position to the actuator firstposition. Alternatively, with respect to medical device 710, adistally-directed force can be applied to the actuator to advance theactuator from the actuator first position to the actuator secondposition. Optionally, step 1026 can be omitted from method 1000.

Step 1028 can be accomplished as described above with respect to step920.

While step 1022, step 1024, step 1026, and step 1028 have been describedas separate steps, step 1022, step 1024, step 1026, and/or step 1028 canbe completed in combination with one another.

While various steps, alternative steps, and optional steps have beendescribed above with respect to method 1000, these steps, alternativesteps, and optional steps can be included in, accomplished concurrentlywith, and/or accomplished in the alternative to, the methods, steps,alternative steps, and/or optional steps described above with respectmethod 900.

The foregoing detailed description provides exemplary embodiments of theinvention and includes the best mode for practicing the invention. Thedescription and illustration of embodiments is intended only to provideexamples of the invention, and not to limit the scope of the invention,or its protection, in any manner.

What is claimed is:
 1. A medical device comprising: an elongate memberhaving an elongate member proximal end, an elongate member distal end,and defining a first lumen and a second lumen; a handle disposed on theelongate member and having an actuator moveable between an actuatorfirst position and an actuator second position, the actuator having afirst portion and a second portion; a wire member having a wire memberfirst end attached to the first portion of the actuator and a wiremember second end disposed within the first lumen and attached to theelongate member; and a cannula having a cannula proximal end attached tothe second portion of the actuator and a cannula distal end disposedwithin the second lumen, the cannula moveable between a cannula firstposition when the actuator is in the actuator first position and acannula second position when the actuator is in the actuator secondposition, in the cannula first position the cannula distal end isdisposed at a first location, in the cannula second position the cannuladistal end is disposed at a second location that is proximal to thefirst location; wherein the elongate member is moveable between asubstantially straight configuration when the actuator is in theactuator first position and a curved configuration when the actuator isin the actuator second position.
 2. The medical device of claim 1,wherein the elongate member has an elongate member first portion and anelongate member second portion, the elongate member first portionextending from the elongate member proximal end towards the elongatemember distal end to a location between the elongate member proximal endand the elongate member distal end, the elongate member second portionextending from the elongate member distal end towards the elongatemember proximal end to a location between the elongate member proximalend and the elongate member distal end; wherein the elongate memberfirst portion is formed of a first material and the elongate membersecond portion is formed of a second material; and wherein the secondmaterial is different than the first material.
 3. The medical device ofclaim 1, wherein the elongate member has an elongate member firstportion and an elongate member second portion, the elongate member firstportion extending from the elongate member proximal end towards theelongate member distal end to a location between the elongate memberproximal end and the elongate member distal end, the elongate membersecond portion extending from the elongate member distal end towards theelongate member proximal end to a location between the elongate memberproximal end and the elongate member distal end; wherein the elongatemember first portion is formed of a first material and the elongatemember second portion is formed of a second material; and wherein thesecond material is flexible relative to the first material.
 4. Themedical device of claim 1, wherein a portion of the elongate membercomprises a coil member.
 5. The medical device of claim 1, wherein thehandle comprises a locking mechanism that is adapted to releasably fixthe actuator in the actuator second position.
 6. The medical device ofclaim 1, wherein the cannula distal end comprises an atraumatic tip. 7.The medical device of claim 1, wherein the elongate member defines athird lumen extending from a third lumen first opening on the elongatemember proximal end to a third lumen second opening on the elongatemember distal end; and wherein the cannula defines a fourth lumenextending from a cannula first opening on the cannula proximal end to acannula second opening on the cannula distal end.
 8. The medical deviceof claim 7, wherein the medical device further comprises a secondarydevice having a secondary device proximal end and a secondary devicedistal end; wherein a portion of the secondary device is disposed in thethird lumen; and wherein the secondary device is selected from the groupconsisting of a suction device, grasper, cutting tool, illuminatingmember, optical fiber, camera, chip-in-tip fiber optic, imaging device,and imaging fiber.
 9. The medical device of claim 7, wherein the medicaldevice further comprises a balloon catheter having a main body, the mainbody having a main body proximal end and a main body distal end; andwherein a portion of the balloon catheter is disposed within the fourthlumen.
 10. The medical device of claim 1, wherein the cannula is formedof a substantially rigid material.
 11. A medical device comprising: anelongate member having an elongate member proximal end, an elongatemember distal end, and defining a first lumen and a second lumen; ahandle disposed on the elongate member and having an actuator moveablebetween an actuator first position and an actuator second position, theactuator having a first portion and a second portion; a wire memberhaving a wire member first end attached to the first portion of theactuator and a wire member second end disposed within the first lumenand attached to the elongate member; and a cannula having a cannulaproximal end attached to the second portion of the actuator and acannula distal end disposed within the second lumen, the cannulamoveable between a cannula first position when the actuator is in theactuator first position and a cannula second position when the actuatoris in the actuator second position, in the cannula first position thecannula distal end is disposed at a first location, in the cannulasecond position the cannula distal end is disposed at a second locationthat is proximal to the first location; wherein the elongate member ismoveable between a substantially straight configuration when theactuator is in the actuator first position and a curved configurationwhen the actuator is in the actuator second position; and wherein thecannula is formed of a substantially rigid material.
 12. The medicaldevice of claim 11, wherein the elongate member has an elongate memberfirst portion and an elongate member second portion, the elongate memberfirst portion extending from the elongate member proximal end towardsthe elongate member distal end to a location between the elongate memberproximal end and the elongate member distal end, the elongate membersecond portion extending from the elongate member distal end towards theelongate member proximal end to a location between the elongate memberproximal end and the elongate member distal end; wherein the elongatemember first portion is formed of a first material and the elongatemember second portion is formed of a second material; and wherein thesecond material is different than the first material.
 13. The medicaldevice of claim 11, wherein the elongate member has an elongate memberfirst portion and an elongate member second portion, the elongate memberfirst portion extending from the elongate member proximal end towardsthe elongate member distal end to a location between the elongate memberproximal end and the elongate member distal end, the elongate membersecond portion extending from the elongate member distal end towards theelongate member proximal end to a location between the elongate memberproximal end and the elongate member distal end; wherein the elongatemember first portion is formed of a first material and the elongatemember second portion is formed of a second material; and wherein thesecond material is flexible relative to the first material.
 14. Themedical device of claim 11, wherein a portion of the elongate membercomprises a coil member.
 15. The medical device of claim 11, wherein thehandle comprises a locking mechanism that is adapted to releasably fixthe actuator in the actuator second position.
 16. The medical device ofclaim 11, wherein the cannula distal end comprises an atraumatic tip.17. The medical device of claim 11, wherein the elongate member definesa third lumen extending from a third lumen first opening on the elongatemember proximal end to a third lumen second opening on the elongatemember distal end; and wherein the cannula defines a fourth lumenextending from a cannula first opening on the cannula proximal end to acannula second opening on the cannula distal end.
 18. The medical deviceof claim 17, wherein the medical device further comprises a secondarydevice having a secondary device proximal end and a secondary devicedistal end; wherein a portion of the secondary device is disposed in thethird lumen; and wherein the secondary device is selected from the groupconsisting of a suction device, grasper, cutting tool, illuminatingmember, optical fiber, camera, chip-in-tip fiber optic, imaging device,and imaging fiber.
 19. The medical device of claim 17, wherein themedical device further comprises a balloon catheter having a main body,the main body having a main body proximal end and a main body distalend; and wherein a portion of the balloon catheter is disposed withinthe fourth lumen.
 20. A method of treating tissue in a bodily passagewall defining a bodily passage, the method comprising the steps of:introducing a first medical device having a first proximal end and afirst distal end into said bodily passage such that the first distal endis disposed within the bodily passage, the first medical devicecomprising: an elongate member having an elongate member proximal end,an elongate member distal end, and defining a first lumen and a secondlumen, the elongate member movable between a substantially straightconfiguration and a curved configuration; a handle disposed on theelongate member and having an actuator moveable between an actuatorfirst position and an actuator second position, the actuator having afirst portion and a second portion, in the actuator first position theelongate member is in the substantially straight configuration, in theactuator second position the elongate member is in the curvedconfiguration; a wire member having a wire member first end attached tothe first portion of the actuator and a wire member second end attachedto the elongate member; and a cannula having a cannula proximal endattached to the second portion of the actuator, a cannula distal enddisposed within the second lumen, and defining a cannula lumen, thecannula moveable between a cannula first position when the actuator isin the actuator first position and a cannula second position when theactuator is in the actuator second position, in the cannula firstposition the cannula distal end is disposed at a first location withinthe second lumen, in the cannula second position the cannula distal endis disposed at a second location within the second lumen that isproximal to the first location; advancing the first medical device intosaid bodily passage; advancing the actuator from the actuator firstposition to the actuator second position such that the cannula movesfrom the cannula first position to the cannula second position and theelongate member moves from the substantially straight configuration tothe curved configuration; introducing a second medical device having asecond proximal end and a second distal end into the cannula lumen suchthat the second distal end is disposed with the cannula lumen; advancingthe second medical device through the cannula lumen such that the seconddistal end is disposed distal to the first distal end; providingtreatment using the second medical device; stopping the step ofproviding treatment using the second medical device; withdrawing thesecond medical device from the cannula lumen such that the second distalend is disposed proximal to the first proximal end; withdrawing thefirst distal end from the opening defined by the bodily passage wall;and withdrawing the first medical device from the bodily passage suchthat the first distal end is disposed outside of the bodily passage.